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☐ ☆ ✇ BMJ Open

Efficacy of perioperative intravenous lidocaine infusion on postoperative recovery and analgesia in patients undergoing video-assisted thoracoscopic surgery: study protocol for a randomised, double-blind, placebo-controlled trial

Por: Omindo · W. W. · Xiao · Z. · Wang · X. · Fu · L. · Wang · J. · Zhang · R. · Ping · W. · Zhou · B. · Zhang · N. — Marzo 3rd 2026 at 13:40
Introduction

Despite the minimally invasive nature of video-assisted thoracoscopic surgery (VATS), moderate-to-severe postoperative pain remains frequent and impairs recovery. Intravenous lidocaine possesses multimodal analgesic, antihyperalgesic and anti-inflammatory properties that may improve pain control and functional outcomes, but robust evidence in thoracic surgery is lacking. Moreover, its potential to attenuate neuropathic pain, a key component of chronic post-thoracic pain syndromes, has not been adequately investigated. This trial will determine whether continuous perioperative intravenous lidocaine infusion improves recovery, reduces acute pain intensity and prevents the development of neuropathic pain after VATS.

Methods and analysis

This single-centre, randomised, double-blind, placebo-controlled trial will enrol 84 adult patients undergoing elective VATS. Participants will be randomised (1:1) to receive either intravenous lidocaine (bolus 1 mg/kg at induction followed by continuous infusion at 1.5 mg/kg/hour intraoperatively and postoperatively for 24 hours) or matched normal saline postoperatively, with identical intraoperative management in both groups. The primary outcome is the incidence of moderate-to-severe movement-evoked pain at 24 hours postoperatively. Secondary outcomes include pain at 48 and 72 hours, opioid consumption, pulmonary complications, sleep quality, quality of recovery, neurocognitive outcomes and chronic neuropathic pain at 3 months. Analyses will follow the intention-to-treat principle.

Ethics and dissemination

The study protocol was approved by the Institutional Review Board of Tongji Hospital (Reference No. TJ-IRB202509102) and registered in the Chinese Clinical Trial Registry (ChiCTR2500111163). Written informed consent will be obtained from all participants. Results will be submitted to peer-reviewed journals and academic conferences.

Trial registration number

ChiCTR2500111163.

☐ ☆ ✇ BMJ Open

Effect of perioperative esketamine administration for postoperative sleep disturbance following general anaesthesia: protocol for a planned systematic review and meta-analysis of randomised controlled trials

Por: Yin · H. · Wang · S. · Huang · H. — Marzo 3rd 2026 at 13:40
Introduction

Postoperative sleep disturbance (PSD) is a common complication following major surgery, occurring in 15%–72% of patients. PSD poses a significant threat to both postoperative recovery and long-term outcome, leading to elevated risks of cognitive decline, pain sensitivity and cardiovascular events in patients. The current pharmacological treatments for PSD are typically reactive, administered only after symptoms have manifested, highlighting a critical unmet need for effective prophylactic strategies during the perioperative period. Recently, an increasing number of studies have demonstrated the effect of esketamine on preventing PSD, but their findings are inconsistent. This protocol outlines a systematic review and meta-analysis to examine the effect of perioperative esketamine on the prevention of PSD.

Methods and analysis

A comprehensive search will be conducted in MEDLINE (via Ovid), EMBASE (via Ovid), the Cochrane Central Register of Controlled Trials (via Ovid), PubMed and Web of Science by two authors independently. The search terms will comprise indexed and free-text terms to encompass the concepts of esketamine and PSD. The primary outcome is the incidence of PSD at postoperative days 1, 3 and 7. Two authors will independently conduct study screening, data extraction and risk of bias assessment with the Cochrane Collaboration’s tool. RevMan V.5.4.1 and Stata V.17.0 software will be used to conduct the statistical analysis. Subgroup analysis, sensitivity analysis and assessment of publication bias will be performed to verify the strength of our conclusions. Finally, the Grading of Recommendations Assessment, Development and Evaluation approach will be used to recommend evidence quality.

Ethics and dissemination

Ethical approval is not required for this study. The findings will be presented at national or international conferences and submitted to a peer-reviewed journal.

PROSPERO registration number

CRD420251232636.

☐ ☆ ✇ BMJ Open

Effect of bupivacaine combined with morphine intrathecal injection on postoperative recovery quality in patients undergoing pulmonary surgery: a study protocol for a multicentre, randomised, double-blind, controlled trial

Por: Yang · D. · Zhao · M. · Tang · S.-H. · Gong · Y. · Xia · H. · Jiang · M. · Peng · K. · Lai · H. · Han · Q. · Zheng · Z. · Gong · Y. · Zhang · J. — Febrero 26th 2026 at 13:47
Introduction

Acute pain following pulmonary surgery can affect the recovery process of patients. The use of intrathecal morphine (ITM) injections offers a long-lasting analgesic effect, but its clinical application remains controversial. This study aims to investigate the impact of combining bupivacaine with ITM injections on the quality of postoperative recovery in patients who have undergone pulmonary surgery.

Methods and design

This multicentre, randomised, double-blind, controlled trial will enrol 254 patients undergoing elective lung surgery, who will be randomly assigned in a 1:1 ratio to either group IT (receiving an intrathecal injection of 3 mg bupivacaine and 0.25 mg morphine before general anaesthesia induction) or the control group (C group). The primary outcome includes postoperative recovery quality on day 1 (quality of recovery, QoR-15), with secondary outcomes encompassing postoperative recovery quality on days 2 and 3 (QoR-15), pain scores within 72 hours postoperatively, analgesic rescue, intraoperative haemodynamic parameters, opioid consumption, postoperative adverse reactions, recovery metrics, complications, chronic pain incidence and sleep quality.

Ethics and dissemination

The results will be disseminated through peer-reviewed publications. This study protocol (V.2.0, 30 October 2024) involves human participants and has been approved by the Ethics Committee of Affiliated Hospital of Yangzhou University (number 2024-08-02-2), Taicang Hospital Affiliated to Soochow University (number 2025 SR-041) and Yichang Central People’s Hospital (number 2024-513-02). Each individual who agrees to participate in the research will provide written informed consent after the objectives and procedures of this study are explained to them.

Trial registration number

ChiCTR2400092935. Registered on 26 November 2024.

☐ ☆ ✇ BMJ Open

Effect of preventive precision multimodal analgesia (PPMA) on postoperative acute pain process and rehabilitation in adult patients undergoing thoracoscopic pulmonary resection: protocol for a prospective, multicentre, randomised controlled study

Por: Fan · Z. · Zhang · Y. · Lei · Q. · Ma · H. · Zhu · X. · Yao · L. · Li · L. · Zheng · H. · Jin · H. · Gao · J. · Ge · Y. · Lin · J. · Lv · J. · Wang · X. · Xiao · Z. · Xiao · W. · Wang · T. — Febrero 22nd 2026 at 18:08
Introduction

Postoperative acute pain following video-assisted thoracoscopic surgery (VATS) impedes patient rehabilitation. While multimodal analgesia effectively mitigates postoperative acute pain and facilitates the postoperative rehabilitation process, the efficacy of preventive precision multimodal analgesia (PPMA) remains uncertain. This study designs a PPMA strategy targeting incisional pain, inflammatory pain and visceral pain in VATS. It aims to investigate the impact of the PPMA strategy on the postoperative acute pain process and rehabilitation outcomes.

Method and analysis

This multicentre, single-blinded, randomised controlled trial will enrol adult patients scheduled for elective thoracoscopic lobectomy or segmentectomy. A total of 1372 participants will be recruited and randomly allocated in a 1:1 ratio to either the preventive precision multimodal analgesia group (PPMA Group) or the conventional multimodal analgesia group (CMA Group). Patients in the PPMA Group will receive a regimen consisting of local anaesthetic infiltration of surgical incision (for incisional pain), intravenous injection of oxycodone (for visceral pain) and parecoxib sodium (for inflammatory pain) before surgery initiation. Patients in the CMA Group will receive the same regimen after specimen isolation. This trial will be conducted across 13 medical centres in China from 2023 to 2026. The primary outcome is the duration of postoperative acute pain. Secondary outcomes include postoperative analgesic consumption, postoperative pain scores, intraoperative haemodynamic parameters and the Indexes of Consciousness (IoC1 and IoC2), as well as intraoperative arterial blood gas and ventilation parameters, intraoperative dosages of general anaesthesia, inflammatory markers at predefined time points, postoperative rehabilitation process and perioperative adverse events and complications.

Ethics and dissemination

This study has been approved by the Ethics Committee of Xuanwu Hospital, Capital Medical University (Linyanshen[2023]-NO.012-003-Revised Vision 1). The results will be published in a peer-reviewed journal.

Trial registration number

Chinese Clinical Trial Registry (ChiCTR2300072176).

☐ ☆ ✇ BMJ Open

Effect of preoperative liposomal bupivacaine single-injection pericapsular nerve group (PENG) block on lower extremity deep vein thrombosis in elderly patients with hip fractures: a randomised controlled, double-blind, prospective clinical study protocol

Por: Peng · H. · Wen · J. · Chen · M. · Jiang · Y. · Ou · J. · Wu · X. — Febrero 22nd 2026 at 18:08
Introduction

Deep vein thrombosis (DVT) of the lower limbs has a significantly higher incidence among elderly populations than that observed in other types of fractures, prolonged immobilisation and the systemic inflammatory response triggered by preoperative pain are the main risk factors. Liposomal bupivacaine (LB) single-injection pericapsular nerve group (PENG) block has demonstrated effective analgesia both before and after surgery, while preserving motor function in patients with hip fracture. Although regional nerve block is a well-established component of preoperative multimodal analgesia, its potential role and underlying mechanisms in the prevention of DVT in elderly patients with hip fracture remain largely unexplored.

Methods and analysis

This study will be conducted as a double-blind, randomised, sham-controlled, prospective clinical trial. On admission, a total of 132 participants will be randomly assigned using block randomisation to receive either treatment group (LB single-injection PENG block) or sham group (saline solution single-injection PENG block). The primary outcome was the incidence of DVT, while secondary outcomes included perioperative inflammatory and immune-related stress levels and functional-based pain scores.

Ethics and dissemination

This study protocol complies with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 guidelines and has been approved by the Ethics Committee of Shunde Hospital, Guangzhou University of Traditional Chinese Medicine (Approval No KY-2025005). The raw data are planned to be made publicly available on the ResMan raw data–sharing platform (IPD sharing platform) of the Chinese Clinical Trial Registry in December 2027 and can be accessed at http://www.medresman.org.cn.

Trial registration number

ChiCTR2500100799.

☐ ☆ ✇ BMJ Open

Analgesic efficacy of peri-operative methadone in orthopaedic surgery: protocol for a systematic review of randomised controlled trials

Por: Evaldsson · B. B. · Nygaard · K. H. · Petersen · S. R. · Moos · C. M. · Stroem · T. · Specht · K. · Schonnemann · J. O. — Febrero 22nd 2026 at 18:08
Introduction

Optimising post-operative pain management is crucial for recovery in orthopaedic surgery. Methadone has attracted interest due to its long half-life, N-methyl-D-aspartate -receptor antagonism and potential to reduce post-operative opioid consumption. Existing reviews combine multiple surgical populations, limiting applicability to orthopaedic settings. This protocol outlines a systematic review assessing the analgesic efficacy and safety of peri-operative methadone in adult and adolescent orthopaedic patients.

Methods and analysis

This review will include randomised controlled trials evaluating intravenous peri-operative methadone vs placebo or standard analgesic regimens in orthopaedic surgery. Primary outcomes are post-operative rescue opioid consumption and pain intensity within 72 hours. Secondary outcomes include adverse events, mobility scores and the length of hospital stay. If available data permit, a methadone dose–response pattern may be investigated. Searches will be conducted in MEDLINE (Ovid), Embase (Ovid), CINAHL, CENTRAL, Web of Science and ClinicalTrials.gov without date restrictions. Two reviewers will independently screen studies, extract data and assess risk of bias using the Cochrane risk-of-bias tool for randomised trials. When appropriate, random-effects meta-analysis methods will be performed. Certainty of evidence will be assessed using Grading of recommendations assesment, development and Evaluation (GRADE).

Ethics and dissemination

As this study uses previously published data, ethical approval is not required. Findings will be disseminated through a peer-reviewed publication and conference presentations.

PROSPERO registration number

CRD42025616291.

☐ ☆ ✇ BMJ Open

Enhancement of the capacity of a healthcare team through real-time information-sharing using a wireless intercom system: a prospective simulation study

Por: Sato · H. · Kuwabara · D. · Minoguchi · K. · Masubuchi · T. · Matsumoto · M. · Okuyama · Y. · Kawakami · H. · Abe · T. · Nakamura · K. · Goto · T. · Nakajima · K. — Febrero 19th 2026 at 12:57
Objectives

Rising patient numbers and limited resources are creating a challenging environment for healthcare providers recently. Anaesthesiologists are also increasingly faced with complex situations, requiring high adaptability in the operating room. To enhance team adaptability during emergencies, effective communication methods are essential. This study aimed to compare the impact of mobile phones and intercoms on the response time and effectiveness of anaesthesiologist teams in emergency situations.

Design

Prospective, observational and simulation study.

Setting

Anaesthesiology and Critical Care, Yokohama City University Medical Center, Yokohama, Japan.

Participants and methods

This study, conducted at Yokohama City University Medical Center (Yokohama, Japan), evaluated how communication methods (intercoms vs mobile phones) impact the efficiency of anaesthesiologists in the simulation setting. Two scenarios were tested: (1) retrieving a video laryngoscope during a difficult intubation and (2) gathering support during cardiac arrest.

Primary and secondary outcome measures

Outcomes measured included time to secure equipment, time for assistance to arrive and staff numbers gathered. The Wilcoxon signed-rank test was used to compare the outcomes between the intercom and mobile phone groups.

Results

In scenario 1, the time to secure the video laryngoscope was significantly shorter with intercom use compared with mobile phones (intercom vs mobile phone, median (IQR): 29 (25–33) s vs 50 (39–62) s; p=0.013, effect size 20 (95% CI 7 to 31)). In scenario 2, the time from the request for assistance until the first supporting staff member reached the operating room was significantly shorter in using the intercoms (intercom vs mobile phone, median (IQR): 16 (14–18) s vs 35 (31–38) s; p=0.04, effect size 17 (95% CI 6 to 24)), and more personnel were available in the intercom group (intercom vs mobile phone, median (IQR): 3 (3–3.5) persons vs 2 (1–2) persons; p=0.04, effect size 1.5 (95% CI 1 to 3)).

Conclusion

Real-time information sharing through intercoms improved the ability of the anaesthesiologist team to respond more rapidly and effectively in emergency situations, enhancing overall team adaptability. This approach may improve patients’ outcomes by shortening response times and increasing team coordination.

☐ ☆ ✇ BMJ Open

Anaesthesia workforce distribution, practices and essential resources in Sierra Leone: a nationwide, cross-sectional, facility-based study

Por: Ovreas · E. · Vreede · E. · van Duinen · A. J. · Svengaard · M. · Furre · M. E. · Kamara · A. K. · Sesay · D. A. · Lonnee · H. · Nathani · P. · Kabba · M. S. · Bolkan · H. A. — Febrero 18th 2026 at 14:51
Objectives

To assess anaesthesia capacity and practice in Sierra Leone by enumerating the anaesthesia workforce by volume, training level and distribution across urban and rural areas and facility ownership; estimating the prevalence of anaesthesia methods used for common surgical procedures by provider category; and evaluating hospital infrastructure and the availability of essential anaesthesia-related medications and equipment.

Design

A nationwide, cross-sectional, facility-based study combining structured questionnaires administered through face-to-face interviews with facility leads and retrospective review of surgical and anaesthesia logbooks.

Setting

Public and private hospitals and clinics in Sierra Leone providing surgical care with general, regional or local anaesthesia within an operating theatre.

Participants

69 of 78 eligible surgical facilities nationwide were included. Facilities providing surgical services between September 2022 and August 2023 were eligible; facilities without registries or declining participation were excluded.

Results

Across participating facilities, the anaesthesia workforce comprised 198 full-time positions, predominantly non-physician providers, with only 40.4% (80/198) trained to administer anaesthesia independently. Ketamine-based and spinal anaesthesia were most common, while general anaesthesia with a protected airway accounted for just 5.0% (415/8339) of procedures. Anaesthesia practices varied by provider training level. Essential infrastructure, equipment and medications fell below international minimum standards, with shortages most pronounced in rural facilities.

Conclusions

Severe shortages of certified anaesthesia providers, limited anaesthesia techniques and inadequate material resources remain major barriers to safe anaesthesia and surgical care in Sierra Leone. Targeted investments in workforce development, infrastructure and resource allocation—particularly in rural areas—are required to improve the safety, quality and equity of anaesthesia care nationwide.

☐ ☆ ✇ BMJ Open

Use of smart glasses for ultrasound-guided radial arterial catheterisation in obese patients: study protocol for a single-centre randomised clinical trial in China

Por: Wang · Y. · Yu · Q. · Xue · T. · Guo · E. · Wu · Y. — Febrero 15th 2026 at 19:02
Introduction

Ultrasound guidance improves the success rate and efficiency of radial arterial catheterisation (RAC). However, the procedure remains more challenging in obese patients, in whom excess subcutaneous tissue can impair anatomical visualisation. Additionally, frequent head shifts between the procedural site and ultrasound screen usually increase procedural complexity, prolong the procedural time and adversely affect both patient comfort and clinician performance. Smart glasses that project real-time ultrasound images directly into the clinician’s field of view offer a potential solution. The study aimed to evaluate whether the use of smart glasses improves the efficiency of ultrasound-guided RAC in obese patients.

Methods and analysis

In this prospective, single-centre, randomised controlled trial, a total of 176 eligible obese patients (body mass index ≥30 kg/m²) requiring RAC for perioperative monitoring will be enrolled. Participants will be randomly assigned in a 1:1 ratio to either the control group, receiving conventional ultrasound-guided RAC, or the smart-glasses group, undergoing ultrasound-guided RAC with real-time image display and needle-tracking assistance via smart glasses. The primary outcome is the first-attempt success rate. Secondary outcomes include the second-attempt success rate, time to successful catheterisation within the first and second attempts, overall procedural time, overall number of arterial catheterisation attempts; ultrasound scanning time, number of probe repositionings and needle redirections; incidence of RAC-related complications, and satisfaction scores of both patients and clinicians. Statistical analyses will be performed using Statistical Package for the Social Sciences (SPSS) and GraphPad Prism.

Ethics and dissemination

This study will be conducted in accordance with the principles of the Declaration of Helsinki. Written informed consent will be obtained from all participants before enrolment. The study protocol has been reviewed and approved by the Medical Research Ethics Committee of the Second Affiliated Hospital of Anhui Medical University. This study has been prospectively registered at Chinese Clinical Trial Registry. Study results will be disseminated through presentations at scientific conferences and publication in peer-reviewed scientific journals.

Trial registration number

ChiCTR2500108023.

☐ ☆ ✇ BMJ Open

Central venous versus short midline catheter in difficult intravenous access patients: a randomised clinical pilot trial

Por: Mellander · C. · Seifert · S. · Hammarskjöld · F. · Taxbro · K. — Febrero 12th 2026 at 19:06
Background

Patients with difficult intravenous access (DIVA) are at increased risk of delays, discomfort and complications due to multiple failed intravenous access attempts. However, evidence comparing commonly used alternatives, short midline catheters (SMLs) and central venous catheters (CVCs) in this population is limited.

Objective

To evaluate the feasibility of a larger randomised controlled trial comparing SMLs with CVCs in DIVA patients using predefined feasibility outcomes.

Design

This trial was a pragmatic, open-label, single-centre, randomised controlled pilot trial with 1:1 randomisation. Participants were recruited from January to August 2025 with follow-up until September 2025.

Setting

Ryhov County Hospital, Jönköping, a teaching county hospital in Sweden.

Participants

Adult patients (≥18 years) with DIVA, requiring intravenous therapy for 4–29 days.

Interventions

Patients received either a 10-cm SML in the upper arm or a single- or double-lumen CVC in the jugular or subclavian vein.

Primary and secondary outcome measures

Primary outcomes were feasibility criteria: eligibility, recruitment, retention, adherence, missing data and skin puncture attempts. Secondary outcomes included insertion and dwell time, and catheter complications (infection, thrombosis and malfunction).

Results

Of 73 patients screened, 40 (55%) were eligible and 30 (75%) (15 males (50%); median (IQR) age, 73 (61–82) years) were randomised to receive SML (n=15) or CVC (n=15). Three patients in the SML group were not included in the data analysis due to one failed insertion and two incomplete follow-ups. Retention (93%), adherence (97%) and missing data (0%) fulfilled predefined thresholds. The only criterion not met was the number of skin puncture attempts, with 52% of patients requiring two or more. Median catheter dwell time was 5.5 days for SML and 4.0 days for CVC. Complication rates per 1000 catheter days were 101.4 for SML versus 9.1 for CVC, primarily due to a higher rate of malfunction in SML (58% versus 7%). No infections or thromboses were observed.

Conclusion

This pilot trial met all but one feasibility criterion, demonstrating that a larger randomised controlled trial is achievable. The findings highlight practical challenges, particularly related to puncture attempts and catheter performance, that should be addressed in the design of a definitive trial.

Trial registration number

NCT06719869.

☐ ☆ ✇ BMJ Open

Awake suction tracheal extubation using a tracheal tube as a suction catheter: study protocol for a randomised controlled non-inferiority trial

Por: Wen · G. · Xu · Y. · Yu · Y. · Pu · Y. · Gu · C. · Dai · L. · Huang · B. — Febrero 12th 2026 at 14:16
Introduction

During recovery from general anaesthesia with tracheal intubation, the tracheal extubation is a necessary step. 22% of anaesthesia-related complications occur after extubation. In a few patients, the hypoxic brain injury and death may occur. Inflation and suction techniques are two common techniques for tracheal extubation; however, it is unclear which technique is superior. In our practice, the suction tracheal extubation is typically performed via a suction catheter, and the tracheal and oropharyngeal secretions are often not completely cleared. Additionally, cough often occurs. When a suction catheter is substituted with a tracheal tube, the clearance of tracheal and oropharyngeal secretions seems to improve. In addition, even without prior tracheal and oropharyngeal suctions before tracheal extubation, the tracheal and oropharyngeal secretions can be effectively cleared when a tracheal tube is used as a suction catheter. This study was designed to investigate the use of tracheal tubes as suction catheters in awake suction tracheal extubation.

Methods and analysis

This single-centre, single-blinded, prospective, non-inferiority, randomised controlled trial will include 600 patients (aged 18–65 years, American Society of Anesthesiologists score suction catheter, Suctiontracheal tube-1 and Suctiontracheal tube-2 groups. In the Inflation group, a positive airway pressure will be given via the anaesthesia machine during awake tracheal extubation. In the Suctionsuction catheter group, negative pressure suction will be implemented during awake tracheal extubation by inserting a suction catheter into the trachea. In the Suctiontracheal tube-1 and Suctiontracheal tube-2 groups, negative pressure suction will be applied during awake tracheal extubation by directly connecting the tracheal tube with a negative pressure suction device. In the Inflation, Suctionsuction catheter and Suctiontracheal tube-1 groups, the tracheal and oropharyngeal suctions under anaesthesia state will be carried out before cuff deflation and removal of the tracheal tube. In the Suctiontracheal tube-2 group, the tracheal and oropharyngeal suctions will not be performed. The primary outcome is the incidence of blood oxygen saturation

Ethics and dissemination

This study was approved by the Ethics Committee of Shenzhen Traditional Chinese Medicine Hospital, The Fourth Clinical Medical College of Guangzho University of Chinese Medicine (Permit No. K2022-162-01, Chairperson Professor Mingzhen Xu) on 17 October 2022 and was registered at the Chinese Clinical Trial Registry (https://www.chictr.org.cn/usercenter.aspx) on 18 November 2022 (identifier ChiCTR2200065904). The study results will be disseminated through peer-reviewed journals, professional societies and meetings.

Trial registration number

ChiCTR2200065904.

☐ ☆ ✇ BMJ Open

Advancing Strategies to Optimise the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) study: rationale and design for a sequential, repeated crossover trial

Por: Stallings · E. G. · Wanderer · J. P. · Balavage · M. · Henson · C. P. · Fowler · L. · Eden · S. · Shotwell · M. S. · Gruss · C. · Neuhafen · K. R. · Gelfand · B. J. · Kertai · M. D. · for the ASPIRE-PONV Investigators — Febrero 10th 2026 at 14:17
Introduction

This project, in adult surgical patients, will evaluate whether the creation of a customised checklist, driven by a clinical decision support tool, is able to improve anaesthesia providers’ adherence to consensus guidelines and standardised practice recommendations for the prevention of postoperative nausea and vomiting (PONV).

Methods and analysis

The intervention will be evaluated using a sequential, repeated crossover design at the institutional level, with designated washout, control and intervention periods. The surgical case will serve as the unit of analysis. The primary outcome is adherence to appropriate PONV prophylaxis administration guidelines. Secondary outcomes include the incidence of PONV and length of stay in the postanaesthesia care unit (PACU).

Ethics and dissemination

This protocol and statistical analysis plan provide an outline of the study design, primary and secondary end points and analytic approach. The Advancing Strategies to Optimise the PerIopeRativE Management of PostOperative Nausea and Vomiting trial has received approval from the Vanderbilt University Institutional Review Board (IRB: 250773). The results will be disseminated through peer-reviewed publications and presentations at national conferences. Findings from this trial will inform best practices for timely antiemetic prophylaxis, with the goal of reducing PONV incidence and shortening PACU stay.

Trial registration number

NCT07152249.

☐ ☆ ✇ BMJ Open

Multicentre international observational study on airway management for anaesthesia: the STARGATE study protocol

Por: Russotto · V. · Sansovini · C. · Muraccini · M. · Collino · F. · Myatra · S. N. · Higgs · A. · Brewster · D. · Curic Radivojevic · R. · Parotto · M. · Karamchandani · K. · Landoni · G. · Sorbello · M. · Monfroglio · M. · Rovescala · G. · Martinelli · P. · Tinelli · O. · Meessen · J. · Be — Febrero 6th 2026 at 14:29
Introduction

More than 300 million major surgical procedures are carried out under general anaesthesia each year worldwide, and advanced airway management remains one of the leading daily challenges for clinicians. Data from large international prospective cohort studies on adverse events such as cardiovascular collapse, cardiac arrest and severe hypoxaemia during advanced airway management to facilitate anaesthesia are lacking.

Methods and analysis

The International obServational sTudy on AiRway manaGement in operAting room and non-operaTing room anaEsthesia (STARGATE) study will be an international prospective observational cohort study describing the incidence of major adverse events associated with advanced airway management (tracheal intubation or supraglottic airway device placement) for general anaesthesia in the operating and non-operating room for surgery and medical procedures. The secondary aim will be to describe the practice of airway management in a large international cohort. Critically ill patients will be excluded from this study. Data on patients’ characteristics, type of procedure and the adopted airway management strategy, post-procedure adverse events, operator characteristics and in-hospital mortality will be prospectively collected. The study aims to enrol 10 500 patients.

Ethics and dissemination

The study has been approved by the Ethics Committee of the coordinating centre (Comitato Etico Interaziendale AOU San Luigi Gonzaga, N° 25/2023). Each of the participating centres will then seek approval of their local Ethics Committee before enrolment. Data will be disseminated to the scientific community by original articles submitted to international peer-reviewed journals.

Trial registration number

NCT05759299.

☐ ☆ ✇ BMJ Open

Perioperative intravenous fluid management in paediatric surgery: a scoping review protocol

Por: Sanchez · V. L. · Pinzon Rodas · V. · Cabra-Bautista · G. · Florez · I. D. · Klimek · M. · Calvache · J. A. — Febrero 6th 2026 at 14:29
Introduction

Intravenous fluids are essential components of perioperative care, supporting intravascular volume, acid–base balance and electrolyte homeostasis. Despite extensive research in adult surgical populations, paediatric-specific evidence remains limited, and clinical practice frequently relies on extrapolated adult-based recommendations. This gap is particularly relevant in paediatric non-cardiac surgery, where fluid choice may influence key physiological outcomes such as acid–base status, electrolyte balance, renal function and haemodynamic stability. Given the heterogeneity of study designs, perioperative phases, age groups and reported outcomes in the paediatric literature, a comprehensive synthesis of the existing evidence is needed before a systematic review can be undertaken.

Methods and analysis

We will conduct this scoping review following the methodological guidance of the Joanna Briggs Institute Manual for Evidence Synthesis, and the reporting will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guideline.

This scoping review will map existing evidence on perioperative intravenous fluid management in paediatric patients (

Eligibility is framed using participants, concept and context: paediatric patients (

Ethics and dissemination

This scoping review involves no primary data collection and relies exclusively on published literature; therefore, formal ethical approval is not required. The protocol received administrative approval from the Comité de Ética para la Investigación Científica of Universidad del Cauca (approval no. 6553, 11 June 2025). Findings will be disseminated through peer-reviewed publications, conference presentations and targeted communication with paediatric anaesthesia and surgical communities.

☐ ☆ ✇ BMJ Open

Ultra long peripheral catheter versus accelerated Seldinger technique long peripheral catheter in difficult intravenous access patients (ULAST): a pragmatic randomised controlled trial protocol

Por: Pieteraerens · W. · Vanhonacker · D. · Beeckman · K. · Torsy · T. — Febrero 6th 2026 at 14:29
Introduction

Ultrasound-guided peripheral cannulation by specialised nurses is increasingly used to improve first-stick success rates in patients with difficult intravenous access (DIVA). Long peripheral catheters are indicated for extended dwell times and the reduction of central venous catheters and their associated complications. Recently, multiple types of catheters and insertion techniques have been used in clinical care.

Methods and analysis

This prospective, two-arm, single-centre, non-blinded, pragmatic randomised controlled trial will compare two types of long peripheral catheters. A 63 mm ultra-long peripheral catheter using the catheter-over-needle approach will be compared with an 80–100 mm accelerated Seldinger technique-long peripheral catheter, which is the standard of care. Adult inpatients with DIVA, requiring a long peripheral catheter, will be included. The study aims to compare the mean dwell time, therapy completion rates and incidences of catheter-related thrombosis, infections, phlebitis, infiltration, loss of catheter usability and unplanned removal among adult DIVA patients. A priori sample size calculation based on average dwell times from published studies indicates that a minimum of 52 patients (26 per group) is needed. Consecutive sampling will be used until the sample size is reached. Upon signing the informed consent form, patients will be randomised in a 1:1 ratio using sequentially numbered, opaque, sealed envelopes. Due to the distinct visual differences between the two types of long peripheral catheters, blinding the inserter during the procedure is impractical.

Ethics and dissemination

The ethics committee of Ghent University (B6702024000487) and University Hospital of Brussels approved this study. On completion of the study, results will be disseminated via publication in a relevant peer-reviewed scientific journal. No external funding was received for the execution of this trial. The authors declare no conflicts of interest.

Trial registration number

NCT07005310.

Protocol version

Version 1, 17/03/2025.

☐ ☆ ✇ BMJ Open

Exploring the dimensions of role transition to clinical educator among masters anaesthesia students in Iran: protocol for a sequential multimethod study (exploratory-analytical)

Por: Shamsi · A. · Yarahmadi · S. · Abolhassani zeraat kar · A. · Shahidi Delshad · E. — Febrero 5th 2026 at 13:02
Introduction

The transition from clinical practice to an academic role presents a multifaceted challenge for anaesthesia master’s students in Iran, as it demands not only clinical expertise but also the development of educational competencies. This protocol outlines a sequential multimethod study designed to explore the dimensions of this role transition, identify the challenges and facilitators inherent in assuming a clinical educator role, and ultimately provide a foundation for evidence-based educational interventions.

Methods and analysis

This sequential multimethod protocol comprises three phases. Phase I involves qualitative thematic content analysis using semistructured focus groups and, where necessary, individual interviews with MSc anaesthesia students to explore experiences of role transition. Qualitative data will be analysed using Braun and Clarke’s six-phase approach. Phase II consists of an integrated review of the literature to synthesise existing evidence on transition to clinical educator roles in anaesthesia and related healthcare disciplines. Phase III integrates findings from both phases using the Pillar Integration Process to generate a comprehensive, evidence-informed framework of role transition.

Ethics and dissemination

Ethical approval for the study has been obtained from Tehran University of Medical Sciences (IR.TUMS.SPH.REC.1403.236), and written informed consent will be secured from all participants. Findings will be disseminated through publications in reputable peer-reviewed journals and presentations at national and international conferences, contributing to the refinement of training programmes for clinical educators within anaesthesia education.

☐ ☆ ✇ BMJ Open

Prophylactic norepinephrine versus phenylephrine infusion on postpartum blood glucose in women undergoing caesarean section: a randomised controlled trial protocol

Por: Zhang · K. · Cao · H. · Ji · H. · Yu · G. · Wu · L. · Shen · Q. · Qian · W. · Tao · W. — Febrero 5th 2026 at 13:02
Introduction

Norepinephrine (NE) and phenylephrine (PE) are routinely administered vasopressors used to maintain haemodynamic stability during caesarean section. Emerging evidence suggests that sustained infusion of these agents may disrupt maternal blood glucose regulation. This randomised controlled trial aims to compare the effects of NE and PE infusion on changes in postpartum blood glucose levels, insulin concentrations and insulin resistance in women after caesarean delivery.

Methods analysis

In this double-blind, randomised trial, 100 eligible parturients will receive prophylactic intravenous infusion of either NE or PE at a rate of 30 mL/hour immediately after subarachnoid anaesthesia, continuing until the end of surgery. The primary outcome is the difference between maternal preoperative and immediate postoperative blood glucose levels. Secondary outcomes include immediate and 6-hour postoperative insulin levels, as well as Homeostasis Model Assessment of Insulin Resistance.

Ethics and dissemination

The Institutional Ethics Committee of Xuancheng People’s Hospital approved the trial protocol (ID: 2025-yjky022-02). Findings will be published in an appropriate journal, and original data will be made available in November 2029 via the ResMan primary data-sharing platform of the China Clinical Trial Registry (http://www.medresman.org.cn).

Trial registration number

ChiCTR2500107683.

☐ ☆ ✇ BMJ Open

The PROTECT trial: Effect of titrated versus conventional induction of general anaesthesia using a target-controlled infusion system on haemodynamics in patients undergoing non-cardiac surgery - protocol for a multicentre, expertise-based randomised contr

Por: Funk · S. · Lohri · M. D. · Kopp Lugli · A. · Schindler · C. · Wiencierz · A. · Mnich · K. · Schläpfer · M. · Gaberdiel · A. P. · Puhan · M. A. · Steiner · L. A. · Gomes · N. V. · Dell-Kuster · S. — Enero 28th 2026 at 14:51
Introduction

Hypotension is a frequent complication after induction of general anaesthesia leading to end-organ injury, for which elderly and multimorbid patients are particularly susceptible. The extent of hypotension depends, among other factors, on the dose and rate of propofol administration. Target-controlled infusion systems are widely used to administer short-acting anaesthetics such as propofol and remifentanil. Commonly, induction is started with a fixed effect-site concentration. Titration, an alternative method of induction using an incremental augmentation of propofol, leads to a reduced induction dose and rate of propofol. We hypothesise that the titration method improves haemodynamic stability compared with conventional induction.

Methods and analysis

This multicentre, expertise-based randomised controlled trial takes place at four Swiss hospitals. Patients ≥55 years of age undergoing non-cardiac surgery under general anaesthesia using propofol target-controlled infusion are randomised to either a conventional or a titrated anaesthesia induction method. Patients, statisticians and, if resources allow, outcome assessors will be blinded. The primary endpoint is the mean arterial pressure under the individual baseline mean arterial pressure (area under threshold) during the first 30 min after start of induction. Secondary endpoints include the maximum deviation from baseline mean arterial pressure, haemodynamic rescue methods, propofol consumption and neurocognitive recovery after regaining consciousness.

A total of 320 patients are required to have an 80% chance of observing superiority of titration for the area under the threshold as significant at the 5% level, assuming a true difference of 100 mm Hg*min. The area under threshold and the maximum deviation will be compared between arms using mixed linear regression models.

Ethics and dissemination

Ethical approval has been obtained from all responsible ethics committees (BASEC2025-01007). The results will be presented at international meetings and published in peer-reviewed journals and may contribute to a change in clinical practice for anaesthesia induction using target-controlled infusion systems with propofol.

Trial registration number

clinicaltrials.gov (NCT06980688) and www.humanforschung-schweiz.ch (HumRes67022).

☐ ☆ ✇ BMJ Open

Femoral versus radial arterial pressure monitoring in cardiac surgery patients: protocol for a randomised controlled multicentric superiority trial (FERARI)

Por: Guinot · P.-G. · Bronnert · R. · Grelet · T. · Bouhemad · B. · Nguyen · M. · Besch · G. · FERARI study group · Berthoud · Kabbout · Radhouani · Martin · Constandache · Durand · GrosJean · Bahr · Anciaux · Bernard · Morgant · Jazzayeri · Bernard · Ghalifa · Lubin · Nays · Guilhot · Al — Enero 28th 2026 at 14:51
Background

Accurate arterial pressure monitoring is critical in cardiac surgery to guide haemodynamic management and vasopressor therapy. Radial arterial pressure monitoring may systematically underestimate central aortic pressure compared with femoral monitoring, potentially leading to inappropriate vasopressor escalation and associated complications. Recent evidence demonstrates that excessive norepinephrine exposure is associated with acute kidney injury and increased mortality in cardiac surgery patients.

Objective

To determine whether femoral arterial pressure monitoring reduces norepinephrine use compared with radial monitoring in cardiac surgery patients.

Methods and analysis

This is a prospective, randomised, controlled, single-blind, superiority trial conducted at two French university hospitals (CHU Besancon and CHU Dijon). Adult patients undergoing cardiac surgery with cardiopulmonary bypass will be randomised 1:1 to receive either femoral or radial arterial pressure monitoring. The primary endpoint is the proportion of patients treated with norepinephrine from anaesthetic induction to postoperative day 7. Secondary endpoints include acute kidney injury according to KDIGO criteria, cardiac complications, vasoactive-inotropic scores, duration of vasopressor therapy, vascular complications, and 7-day and 30-day mortality. Sample size calculation indicates 340 patients (170 per group) are needed to detect a 15% absolute reduction in norepinephrine use with 90% power and α=0.05, and an anticipated loss to follow-up rate of 5%.

Ethics and dissemination

The study has been approved by the French Ethics Committee (Comité de Protection des Personnes Nord-Ouest II, no. 2024/897) and will be conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Results will be submitted for publication in peer-reviewed journals and presented at international conferences.

Trial registration number

NCT06952907.

☐ ☆ ✇ BMJ Open

Effects of low-dose esketamine on hypoxaemia during thoracoscopic non-tracheal intubation anaesthesia: protocol for a double-blind, randomised controlled trial

Por: Tian · J. · Xu · M. · Li · S. · Liu · Y. · Li · W. · Sun · W. · Gu · C. — Enero 27th 2026 at 12:49
Introduction

Non-tracheal intubation anaesthesia for thoracoscopic surgery is associated with intraoperative hypoxaemia. Esketamine has both sedative and analgesic effects, which can increase lung compliance, reduce airway resistance and relax the respiratory smooth muscles. This study will investigate the effectiveness of low-dose esketamine in reducing the incidence of intraoperative hypoxaemia and other adverse events in patients undergoing thoracoscopic surgery without intubation anaesthesia.

Methods and analysis

This randomised controlled trial will enrol patients scheduled for non-intubation video-assisted thoracoscopic surgery at Shandong Provincial Hospital Affiliated to Shandong First Medical University. Eligible participants will be randomly allocated in a 1:1 ratio to receive either the esketamine group or the normal saline (placebo) group. The primary outcomes are the incidence of hypoxaemia and the time to its onset, with hypoxaemia defined as an intraoperative pulse oximetry ≤90% lasting for at least 10 s. Secondary outcomes include the incidence of intraoperative hypercapnia (Partial pressure of carbon dioxide (PCO2) ≥60 mm Hg); concentrations of interleukin (IL)-6 and IL-8 at the end of surgery; postoperative Visual Analogue Scale scores; time to recovery of spontaneous respiration after laryngeal mask placement; time to laryngeal mask removal (measured from the end of surgery); awakening time; incidence of bradycardia (heart rate 20% reduction in blood pressure from the baseline value); incidence of ≤24-hour postoperative nausea and vomiting and hoarseness; time to ambulation, drinking and eating postoperatively; incidence of pulmonary complications within 2 weeks postoperatively; and length of hospital stay. All analyses will be performed based on using a modified intention-to-treat population principle.

Ethics and dissemination

The study protocol has been reviewed and approved by the Ethics Committee of Shandong First Medical University Affiliated Provincial Hospital, with approval number SWYX 2025–714. The trial is also registered with the Chinese Clinical Trial Registry under the identifier ChiCTR2400094821. On completion, the study findings will be prepared for publication and submitted to a relevant peer-reviewed journal.

Trial registration number

ChiCTR2400094821.

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