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Development and applications of the Anaesthetists Non-Technical Skills behavioural marker system: a systematic review

Por: Kang · J. · Hu · J. · Yan · C. · Xing · X. · Tu · S. · Zhou · F.
Objectives

To comprehensively synthesise evidence regarding the validity and reliability of the Anaesthetists’ Non-Technical Skills (ANTS) behavioural marker system and its application as a tool for the training and assessment of non-technical skills to improve patient safety.

Design

Systematic review.

Data sources

We employed a citation search strategy. The Scopus and Web of Science databases were searched for articles published from 2002 to May 2022.

Eligibility criteria

English-language publications that applied the ANTS system in a meaningful way, including its use to guide data collection, analysis and reporting.

Data extraction and synthesis

Study screening, data extraction and quality assessment were performed by two independent reviewers. We appraised the quality of included studies using the Joanna Briggs Institute Critical Appraisal Checklists. A framework analysis approach was used to summarise and synthesise the included articles.

Results

54 studies were identified. The ANTS system was applied across a wide variety of study objectives, settings and units of analysis. The methods used in these studies varied and included quantitative (n=42), mixed (n=8) and qualitative (n=4) approaches. Most studies (n=47) used the ANTS system to guide data collection. The most commonly reported reliability statistic was inter-rater reliability (n=35). Validity evidence was reported in 51 (94%) studies. The qualitative application outcomes of the ANTS system provided a reference for the analysis and generation of new theories across disciplines.

Conclusion

Our results suggest that the ANTS system has been used in a wide range of studies. It is an effective tool for assessing non-technical skills. Investigating the methods by which the ANTS system can be evaluated and implemented for training within clinical environments is anticipated to significantly enhance ongoing enhancements in staff performance and patient safety.

PROSPERO registration number

CRD42022297773.

REKOVER study protocol: a pRospective patient treatment rEgistry of tramadol and dexKetoprofen trometamol oral fixed-dose combination (SKUDEXA) in mOderate to seVere acutE pain in Real-world setting in Asia

Por: Ho · K. Y. · Gyanwali · B. · Dimayuga · C. · Eufemio · E. M. · Bernardo · E. · Raju · G. · Chong · K. W. · Waithayayothin · K. · Ona · L. · Castro · M. A. L. · Sawaddiruk · P. · Salvador · R. C. · Roohi · S. A. · Tangwiwat · S. · Wilairatana · V. · Oon · Z. H. · Gupta · A. · Nagrale · D.
Introduction

Satisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia.

Methods and analysis

REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18–80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.

Ethics and dissemination

The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.

Inhaled Nitric Oxide ReDuce postoperatIve pulmoNAry complicaTions in patiEnts with recent COVID-19 infection (INORDINATE): protocol for a randomised controlled trial

Por: Zheng · Z. · Wang · L. · Wang · S. · Fan · Q. · Zhang · H. · Luo · G. · Gao · B. · Yang · X. · Zhao · B. · Wang · X. · Dong · H. · Nie · H. · Lei · C.
Background

A history of SARS-CoV-2 infection has been reported to be associated with an increased risk of postoperative pulmonary complications (PPCs). Even mild PPCs can elevate the rates of early postoperative mortality, intensive care unit (ICU) admission and prolong the length of ICU and/or hospital stays. Consequently, it is crucial to develop perioperative management strategies that can mitigate these increased risks in surgical patients who have recently been infected with SARS-CoV-2. Accumulating evidence suggests that nitric oxide (NO) inhalation might be effective in treating COVID-19. NO functions in COVID-19 by promoting vasodilation, anticoagulation, anti-inflammatory and antiviral effects. Therefore, our study hypothesises that the perioperative use of NO can effectively reduce PPCs in patients with recent SARS-CoV-2 infection.

Method and analysis

A prospective, double-blind, single-centre, randomised controlled trial is proposed. The trial aims to include participants who are planning to undergo surgery with general anaesthesia and have been recently infected with SARS-CoV-2 (within 7 weeks). Stratified allocation of eligible patients will be performed at a 1:1 ratio based on the predicted risk of PPCs using the Assess Respiratory Risk in Surgical Patients in Catalonia risk index and the time interval between infection and surgery.

The primary outcome of the study will be the presence of PPCs within the first 7 days following surgery, including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm and aspiration pneumonitis. The primary outcome will be reported as counts (percentage) and will be compared using a two-proportion 2 test. The common effect across all primary components will be estimated using a multiple generalised linear model.

Ethics and dissemination

The trial is approved by the Institutional Review Board of Xijing Hospital (KY20232058-F1). The findings, including positive, negative and inconclusive results, will be published in scientific journals with peer-review processes.

Trial registration number

NCT05721144.

High-flow nasal oxygenation versus face mask oxygenation for preoxygenation in patients undergoing double-lumen endobronchial intubation: protocol of a randomised controlled trial

Por: He · R. · Fang · Y. · Jiang · Y. · Yao · D. · Li · Z. · Zheng · W. · Liu · Z. · Luo · N.
Introduction

With the growing emphasis on swift recovery, minimally invasive thoracic surgery has advanced significantly. Video-assisted thoracoscopic surgery (VATS) has seen rapid development, and the double-lumen tube (DLT) remains the most dependable method for tracheal intubation in VATS. However, hypoxaemia during DLT intubation poses a threat to the perioperative safety of thoracic surgery patients. Recently, transnasal high-flow nasal oxygen (HFNO) has shown promise in anaesthesia, particularly in handling short-duration hypoxic airway emergencies. Yet, its application in the perioperative period for patients undergoing pulmonary surgery with compromised cardiopulmonary function lacks evidence, and there are limited reliable clinical data.

Methods and analysis

A prospective, randomised, controlled, single-blind design will be employed in this study. 112 patients aged 18–60 years undergoing elective VATS-assisted pulmonary surgery will be enrolled and randomly divided into two groups: the nasal high-flow oxygen group (H group) and the traditional mask transnasal oxygen group (M group) in a 1:1 ratio. HFNO will be used during DLT intubation for the prevention of asphyxia in group H, while conventional intubation procedures will be followed by group M. Comparison will be made between the two groups in terms of minimum oxygen saturation during intubation, hypoxaemia incidence during intubation, perioperative complications and postoperative hospital days.

Ethics and dissemination

Approval for this study has been granted by the local ethics committee at Shenzhen Second People’s Hospital. The trial results will be disseminated through peer-reviewed journals and scientific conferences.

Trial registration number

NCT05666908.

Comparison of ultrasound-guided subtransverse process interligamentary plane block with paravertebral block for postoperative analgesia in thoracic surgery: protocol for a randomised non-inferiority trial

Por: Wu · W. · Wang · D. · Liu · Y. · Zhu · T. · He · W. · Shi · H.
Introduction

The subtransverse process interligamentary (STIL) plane block is an emerging interfascial plane block that has garnered attention for its potential to provide effective postoperative analgesia for breast and thoracic surgeries. However, a direct comparative assessment between the STIL plane block and the paravertebral block is currently lacking. Consequently, our study aims to assess the analgesic efficacy of the STIL block in comparison to paravertebral block for patients undergoing video-assisted thoracoscopic surgery (VATS).

Methods and analysis

This study is a randomised, parallel-controlled, double-blind, non-inferiority trial, with the goal of enrolling 114 participants scheduled for uniportal VATS at Shanghai Pulmonary Hospital. Participants will be randomly assigned in a 1:1 ratio through block randomisation to receive either the STIL plane block (n=57) or the paravertebral block (n=57). The primary outcome of the study is the area under the curve of Numerical Rating Scale(NRS) scores recorded over a 48-hour period following the surgical procedure. Secondary outcomes encompass the evaluation of Quality of Recovery-40, cumulative sufentanil consumption, serum inflammatory factors, rescue medication usage, the incidence of adverse events and the patient satisfaction scores.

Ethics and dissemination

This study has received approval from the Medical Ethics Committee of Shanghai Pulmonary Hospital (approval no. L22-329). Written informed consent will be obtained from all participants. The findings will be submitted for publication in peer-reviewed journals.

Trial registration number

ChiCTR2200066909.

Effects of opioid-free anaesthesia compared with balanced general anaesthesia on nausea and vomiting after video-assisted thoracoscopic surgery: a single-centre randomised controlled trial

Por: Bao · R. · Zhang · W.-s. · Zha · Y.-f. · Zhao · Z.-z. · Huang · J. · Li · J.-l. · Wang · T. · Guo · Y. · Bian · J.-j. · Wang · J.-f.
Objectives

Opioid-free anaesthesia (OFA) has emerged as a promising approach for mitigating the adverse effects associated with opioids. The objective of this study was to evaluate the impact of OFA on postoperative nausea and vomiting (PONV) following video-assisted thoracic surgery.

Design

Single-centre randomised controlled trial.

Setting

Tertiary hospital in Shanghai, China.

Participants

Patients undergoing video-assisted thoracic surgery were recruited from September 2021 to June 2022.

Intervention

Patients were randomly allocated to OFA or traditional general anaesthesia with a 1:1 allocation ratio.

Primary and secondary outcome measures

The primary outcome measure was the incidence of PONV within 48 hours post-surgery, and the secondary outcomes included PONV severity, postoperative pain, haemodynamic changes during anaesthesia, and length of stay (LOS) in the recovery ward and hospital.

Results

A total of 86 and 88 patients were included in the OFA and control groups, respectively. Two patients were excluded because of severe adverse events including extreme bradycardia and epilepsy-like convulsion. The incidence and severity of PONV did not significantly differ between the two groups (29 patients (33.0%) in the control group and 22 patients (25.6%) in the OFA group; relative risk 0.78, 95% CI 0.49 to 1.23; p=0.285). Notably, the OFA approach used was associated with an increase in heart rate (89±17 vs 77±15 beats/min, t-test: p

Conclusions

Our study findings suggest that the implementation of OFA does not effectively reduce the incidence of PONV following thoracic surgery when compared with traditional total intravenous anaesthesia. The opioid-free strategy used in our study may be associated with severe adverse cardiovascular events.

Trial registration number

ChiCTR2100050738.

Effectiveness of dexmedetomidine during surgery under general anaesthesia on patient-centred outcomes: a systematic review and Bayesian meta-analysis protocol

Por: Verret · M. · Le · J. B. P. · Lalu · M. M. · McIsaac · D. I. · Nicholls · S. · Turgeon · A. F. · Hutton · B. · Zivkovic · F. · Graham · M. · Le · M. · Geist · A. · Berube · M. · Gilron · I. · Poulin · P. · Daudt · H. · Martel · G. · McVicar · J. · Moloo · H. · Fergusson · D. A.
Introduction

Dexmedetomidine is a promising pharmaceutical strategy to minimise opioid use during surgery. Despite its growing use, it is uncertain whether dexmedetomidine can improve patient-centred outcomes such as quality of recovery and pain.

Methods and analysis

We will conduct a systematic review and meta-analysis following the recommendations of the Cochrane Handbook for Systematic Reviews. We will search MEDLINE, Embase, CENTRAL, Web of Science and CINAHL approximately in October 2023. We will include randomised controlled trials evaluating the impact of systemic intraoperative dexmedetomidine on patient-centred outcomes. Patient-centred outcome definition will be based on the consensus definition established by the Standardised Endpoints in Perioperative Medicine initiative (StEP-COMPAC). Our primary outcome will be the quality of recovery after surgery. Our secondary outcomes will be patient well-being, function, health-related quality of life, life impact, multidimensional assessment of postoperative acute pain, chronic pain, persistent postoperative opioid use, opioid-related adverse events, hospital length of stay and adverse events. Two reviewers will independently screen and identify trials and extract data. We will evaluate the risk of bias of trials using the Cochrane Risk of Bias Tool (RoB 2.0). We will synthesise data using a random effects Bayesian model framework, estimating the probability of achieving a benefit and its clinical significance. We will assess statistical heterogeneity with the tau-squared and explore sources of heterogeneity with meta-regression. We have involved patient partners, clinicians, methodologists, and key partner organisations in the development of this protocol, and we plan to continue this collaboration throughout all phases of this systematic review.

Ethics and dissemination

Our systematic review does not require research ethics approval. It will help inform current clinical practice guidelines and guide development of future randomised controlled trials. The results will be disseminated in open-access peer-reviewed journals, presented at conferences and shared among collaborators and networks.

PROSPERO registration number

CRD42023439896.

Effects of liposomal bupivacaine in preoperative fascia iliac block on postoperative pain and delirium in elderly patients undergoing hip fracture surgery: a study protocol for a randomised, parallel controlled prospective clinical study

Por: Hao · Y. · Li · W. · Zheng · M. · Li · X. · Wu · X. · Yu · Z. · Liu · S. · Li · J. · Xu · H.
Introduction

Postoperative delirium (POD) is the most common acute fluctuating mental state change after hip fractures in older adults. Postoperative pain is a Grade A risk factor for POD and is closely related to the prognosis of patients undergoing hip fracture surgery. The fascia iliac block has a definite analgesic effect and few side effects, and several studies have reported that it reduces the occurrence of POD in patients undergoing general anaesthesia for hip fracture surgery. Liposomal bupivacaine is a local anaesthetic with a long half-life that significantly reduces the use of opioids and is conducive to patient prognosis and recovery. However, whether regional nerve block analgesia can decrease the occurrence of POD in elderly patients undergoing hip fracture surgery has not been reported.

Methods and analysis

This is a single-blinded, randomised, parallel-controlled prospective clinical study. Participants will be randomly assigned preoperatively to either the liposomal bupivacaine (ie, Exparel) or ropivacaine groups by block randomisation. Then, the occurrence of POD (primary outcome) and postoperative pain (secondary outcome) will be evaluated.

Ethics and dissemination

This research protocol complies with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 guidelines and is approved by the Ethics Committee of Shanghai General Hospital (ID 2023–437). The original data are expected to be released in July 2029 on the ResMan original data-sharing platform (IPD-sharing platform) of the China Clinical Trial Registry, which can be viewed on the following website: http://www.medresman.org.cn.

PROSPERO registration number

ChiCTR2300074022.

Effectiveness of general anaesthesia with remimazolam tosilate on intraoperative haemodynamics and postoperative recovery: study protocol for a randomised, positive-controlled, pragmatic clinical trial (GARTH trial)

Por: Lu · C. · Kang · Y. · Luo · Q. · Zhong · F. · Cai · Y. · Zhang · G. · Guo · Z. · Zhang · S. · Ma · J. · Shu · H.
Introduction

It is encouraged to estimate the effectiveness of components within the enhanced recovery after surgery (ERAS) protocol through patient-reported outcomes, alongside doctor-reported outcomes and length of hospital stay. At present, studies on the contributions of optimal anaesthetic drugs within the ERAS protocol to patient-reported and doctor-reported outcomes are limited. Therefore, this study aims to pragmatically evaluate the effectiveness and safety of general anaesthesia (GA) with remimazolam tosilate within the ERAS protocol on intraoperative haemodynamics and postoperative recovery in adults undergoing elective surgeries, compared with propofol.

Methods and analysis

This study is a single-centre, randomised, blinded, positive-controlled, pragmatic clinical trial. A total of 900 patients, aged ≥18 years old, scheduled for an elective surgical procedure under GA will be included. Patients will be randomised in a 1:1 ratio to the remimazolam group (the GA with remimazolam tosilate within the ERAS protocol group) or propofol group (the GA with propofol within the ERAS protocol group), stratified by general surgery, thoracic surgery and other surgeries (including urological surgery and otolaryngology surgery). The primary outcomes include the 24-hour postoperative quality of recovery-40 score and the rate of intraoperative hypotension. Secondary endpoints include the rate of sedative hypotension requiring treatment, the haemodynamic profiles, the 72-hour postoperative quality of recovery-40 score, the functional anaesthetic capability, adverse events and complications, quality of life within 3 months as well as economic health outcomes.

Ethics and dissemination

This study protocol has been approved by the ethics committee of Guangdong Provincial People’s Hospital (KY-H-2022-005-03-08). Dissemination plans will be presented at scientific meetings and in scientific publications.

Trial registration number

ChiCTR2200062520

Cannabis for medical use versus opioids for chronic non-cancer pain: a systematic review and network meta-analysis of randomised clinical trials

Por: Jeddi · H. M. · Busse · J. W. · Sadeghirad · B. · Levine · M. · Zoratti · M. J. · Wang · L. · Noori · A. · Couban · R. J. · Tarride · J.-E.
Objective

The objective of this study is to evaluate the comparative benefits and harms of opioids and cannabis for medical use for chronic non-cancer pain.

Design

Systematic review and network meta-analysis.

Data sources

EMBASE, MEDLINE, CINAHL, AMED, PsycINFO, PubMed, Web of Science, Cannabis-Med, Epistemonikos and the Cochrane Library (CENTRAL) from inception to March 2021.

Study selection

Randomised trials comparing any type of cannabis for medical use or opioids, against each other or placebo, with patient follow-up ≥4 weeks.

Data extraction and synthesis

Paired reviewers independently extracted data. We used Bayesian random-effects network meta-analyses to summarise the evidence and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach to evaluate the certainty of evidence and communicate our findings.

Results

Ninety trials involving 22 028 patients were eligible for review, among which the length of follow-up ranged from 28 to 180 days. Moderate certainty evidence showed that opioids provide small improvements in pain, physical functioning and sleep quality versus placebo; low to moderate certainty evidence supported similar effects for cannabis versus placebo. Neither was more effective than placebo for role, social or emotional functioning (all high to moderate certainty evidence). Moderate certainty evidence showed there is probably little to no difference between cannabis for medical use and opioids for physical functioning (weighted mean difference (WMD) 0.47 on the 100-point 36-item Short Form Survey physical component summary score, 95% credible interval (CrI) –1.97 to 2.99), and cannabis resulted in fewer discontinuations due to adverse events versus opioids (OR 0.55, 95% CrI 0.36 to 0.83). Low certainty evidence suggested little to no difference between cannabis and opioids for pain relief (WMD 0.23 cm on a 10 cm Visual Analogue Scale (VAS), 95% CrI –0.06 to 0.53) or sleep quality (WMD 0.49 mm on a 100 mm VAS, 95% CrI –4.72 to 5.59).

Conclusions

Cannabis for medical use may be similarly effective and result in fewer discontinuations than opioids for chronic non-cancer pain.

PROSPERO registration number

CRD42020185184.

Study of postoperative laryngopharyngeal discomfort: protocol for a single-centre cohort study

Por: Wang · L. F. · Zheng · M.-T. · Liang · N. · Ma · H. N. · Li · W. X.
Introduction

Postoperative laryngopharyngeal discomfort after extubation can lead to severe throat pain, dysphagia, or postoperative tongue oedema. Possible mechanisms include increased oral pressure, obstruction of venous and lymphatic return in the neck, and increased capillary hydrostatic pressure, which leads to oedema of the tongue and upper airway. However, real-time monitoring indicators of anaesthesia are lacking. Therefore, we designed this study to accurately measure the contact force of the tracheal tube on the tongue in different surgical positions during general anaesthesia.

Methods and analysis

This prospective single-centre observational study will enrol 54 patients undergoing elective surgery under general anaesthesia for>2 hours with endotracheal tube application from 1 July 2023 to 30 June 2024. Patients will be divided into the supine (Supine group) and high-risk (Flexion group) groups. Dynamic changes in the contact force between the tracheal tube and tongue will be measured using T-Scan technology. All patients will be followed up for 7 days postoperatively. The primary endpoint is postoperative laryngopharyngeal discomfort. Secondary outcomes include the time to the first successful recovery of oral intake of fluids and solid food, and airway-related events.

Ethics and dissemination

Ethical approval was obtained from the Ethics Committee of Clinical Research of China-Japan Friendship Hospital (2023-KY-219, approved on 14 September 2023). Informed consent will be obtained during anaesthesia evaluation. This study aims to explore the characteristics of the contact force on the tongue caused by endotracheal intubation in different surgical positions and to provide a better understanding of the risk factors and prevention of postoperative laryngopharyngeal discomfort. The findings of this study will be presented at our hospital, reported on ClinicalTrials.gov, and published in peer-reviewed journals.

Trial registration number

NCT05987293.

Safety and efficacy of remimazolam tosilate combined with low-dose fentanyl for procedural sedation in obese patients undergoing gastroscopy: study protocol for a single-centre, double-blind, randomised controlled trial

Por: Yan · L. · Wang · X. · Chen · Z. · Wu · N. · Li · H. · Yang · B.
Introduction

Obese patients are susceptible to hypoxaemia during procedural sedation. Propofol combined with low-dose opioids is commonly used as a sedation strategy, but it can exacerbate hypoxaemia by causing cardiopulmonary depression and airway obstruction, especially in obese patients. Remimazolam, a novel ultra-short-acting benzodiazepine, has minimal accumulative effects and less cardiorespiratory depression. This study aims to evaluate the safety and efficacy of combining remimazolam tosilate with low-dose fentanyl as an alternative option for procedural sedation in obese patients undergoing gastroscopy.

Methods and analysis

This randomised controlled trial (RCT) will be conducted in the Endoscopy Centre of the First Affiliated Hospital of Xiamen University, recruiting 174 participants scheduled for painless gastroscopy with a body mass index of 30–39.9 kgxm–2. All patients will be randomly divided into two groups in a 1:1 ratio. The sedation strategy of the intervention group is remimazolam tosilate combined with fentanyl, while the control group is propofol combined with fentanyl. The primary outcome is the incidence of hypoxaemia and the secondary outcomes include the time to ambulation, need for airway manoeuvres and rescue sedation, sleep quality, the incidence of sedation failure, adverse events and the cost of sedatives. All statistical tests will be performed using IBM SPSS V.20.0 statistical software. A p value

Ethics and dissemination

This RCT was reviewed and approved by the Ethics Committee of the First Affiliated Hospital of Xiamen University (Scientific Research Ethics Review 2022, No.093). The results will be published in peer-reviewed journals.

Trial registration number

ChiCTR2200067076.

Financial burden of postoperative complications following oesophagectomy: a scoping review protocol

Por: Buchholz · V. · Berman · J. · Liu · D. · Le · P. · Weinberg · L.
Introduction

The rapid rise in the incidence of oesophageal adenocarcinoma has resulted in an increasing number of patients undergoing oesophagectomy. Although novel surgical techniques are enhancing surgical outcomes, postoperative complications remain pervasive. Despite this, there are limited reviews mapping the cost of postoperative complications following oesophagectomy, and none has compared cost differences between patient groups. Such information would be invaluable in appreciating the financial burden on the healthcare system and serving to guide hospital financing decisions. This scoping review protocol outlines an approach to reviewing the literature to precipitate and inform discussions surrounding financing oesophagectomy procedures as well as funding requirements for upper gastrointestinal surgical units.

Methods and analysis

Adhering to the pertinent components of the Preferred Reporting Items for Systematic Review and Meta-Analysis Extension for Scoping Review Protocols guidelines, a systematic exploration will be conducted across electronic databases, including MEDLINE, EMBASE, the Cochrane Library and Econolit, with further reference tracking of eligible studies. This review will encompass studies related to the costs associated with complications following oesophagectomy. All studies published prior to 31 October 2023 are eligible for inclusion. The process of screening and extracting data will be undertaken by two independent reviewers. Subsequently, the amassed data will be pooled and subjected to comprehensive analysis and presented descriptively, using both a mixed methods and a narrative approach.

Ethics and dissemination

Ethics approval was not required. The results will be communicated through established professional networks, conference presentations and publication in peer-reviewed journals.

Acoustic stimulation for relieving pain during venipuncture: a systematic review and network meta-analysis

Por: Yamada · Y. · Kitamura · M. · Inayama · E. · Kishida · M. · Kataoka · Y. · Ikenoue · T.
Objectives

To assess whether acoustic stimulations relieve venipuncture pain and determine which stimulation is the most effective type.

Design

Systematic review and network meta-analysis.

Data sources

PubMed, Cochrane Central Register of Controlled Trials, Excerpta Medica dataBASE, Cumulative Index to Nursing and Allied Health Literature, ClinicalTrials.gov and the International Clinical Trials Registry Platform databases were systematically searched in September 2023.

Study selection

Randomised controlled trials evaluating the efficacy of acoustic stimulations on patients undergoing venipuncture were eligible. Acoustic stimulations were classified into seven categories: five types of acoustic stimulations (music medicine (researcher selected), music medicine (patient selected), music therapy, sounds with linguistic meaning and sounds without linguistic meaning) and two controls (only wearing headphones and no treatment).

Primary and secondary outcome measures

Primary outcomes included self-reported pain intensity assessed during venipuncture and treatment cost, and secondary outcomes were self-reported mental distress and adverse events.

Results

Of 6406 citations, this network meta-analysis included 27 studies including 3416 participants; the mean age was 31.5 years, and 57% were men. Among the five types of acoustic stimulations, only musical interventions, such as music medicine (patient selected) (standardised mean difference (SMD) –0.44 (95% CI: –0.84 to –0.03); low confidence), music medicine (researcher selected) (SMD –0.76 (95% CI: –1.10 to –0.42); low confidence) and music therapy (SMD –0.79 (95% CI: –1.44 to –0.14); low confidence), were associated with improved pain relief during venipuncture compared with no treatment. No significant differences existed between the types of acoustic stimulations. Free-of-charge acoustic stimulations were provided to patients, and no specific adverse events were reported. In many studies, the risk of bias was rated high because of the difficulty of blinding the intervention to the participants and the self-reported pain outcome.

Conclusions

Music interventions were associated with reduced venipuncture pain. Comparisons between types of acoustic stimulations revealed no significant differences. Therefore, music intervention could be a safe and inexpensive pain relief method for venipuncture.

PROSPERO registration number

CRD42022303852.

Study protocol for a national observational cohort investigating frailty, delirium and multimorbidity in older surgical patients: the third Sprint National Anaesthesia Project (SNAP 3)

Por: Swarbrick · C. · Poulton · T. · Martin · P. · Partridge · J. · Moppett · I. K. · SNAP 3 Project Team · Cortes · Evans · Green · Lourtie · Shah · Taylor · Williams
Introduction

Older surgical patients are more likely to be living with frailty and multimorbidity and experience postoperative complications. The management of these conditions in the perioperative pathway is evolving. In order to support objective decision-making for patients, services and national guidance, accurate, contemporary data are needed to describe the impact and associations between frailty, multimorbidity and healthcare processes with patient and service-level outcomes.

Methods and analysis

The study is comprised of an observational cohort study of approximately 7500 patients; an organisational survey of perioperative services and a clinician survey of the unplanned, medical workload generated from older surgical patients. The cohort will consist of patients who are 60 years and older, undergoing a surgical procedure during a 5-day recruitment period in participating UK hospitals. Participants will be assessed for baseline frailty and multimorbidity; postoperative morbidity including delirium; and quality of life. Data linkage will provide additional details about individuals, their admission and mortality.

The study’s primary outcome is length of stay, other outcome measures include incidence of postoperative morbidity and delirium; readmission, mortality and quality of life. The cohort’s incidence of frailty, multimorbidity and delirium will be estimated using 95% CIs. Their relationships with outcome measures will be examined using unadjusted and adjusted multilevel regression analyses. Choice of covariates in the adjusted models will be prespecified, based on directed acyclic graphs.

A parallel study is planned to take place in Australia in 2022.

Ethics and dissemination

The study has received approval from the Scotland A Research Ethics Committee and Wales Research Ethics Committee 7.

This work hopes to influence the development of services and guidelines. We will publish our findings in peer-reviewed journals and provide summary documents to our participants, sites, healthcare policy-makers and the public.

Trial registration number

ISRCTN67043129.

Benefits of cardiac coherence combined with medical hypnosis on preoperative anxiety before cancer surgery: the COHEC II study trial protocol

Por: Amraoui · J. · Bordenave · L. · Leclerc · G. · Salvignol · G. · Jarlier · M. · Fiess · C. · Philibert · L. · Fuzier · R. · Touraine · C.
Introduction

Preoperative anxiety is a frequent problem that can lead to complications both during anaesthesia and in the postoperative period, especially in oncology. Studies have shown that it can be managed using non-pharmacological approaches, but few works have evaluated psychoeducational programmes. The aim of the COHErence Cardiaque (COHEC) II Study is to evaluate the combination of medical hypnosis (MH) and cardiac coherence (CC) training to manage preoperative anxiety in patients with cancer.

Methods and analysis

COHEC II is an ongoing multicentre randomised clinical trial carried out in three French comprehensive cancer centres. In total, 296 patients who will undergo surgery for cancer will be recruited during 18 months and will be randomised in the control arm or the intervention arm. Patients in the intervention arm will follow a daily programme that combines MH and CC, starting 7 days before surgery. The control arm will receive the standard treatment to manage preoperative anxiety. The primary endpoint is the anxiety level on surgery day, measured using a Visual Analogue Scale. Secondary endpoints are patient adherence to the programme, satisfaction and postsurgery recovery quality.

Ethics and dissemination

The study protocol was approved by the French Ethics Committee (Comité de Protection des Personnes EST-II) on 24 November 2021 and will be carried out following the good practice guidelines and the Declaration of Helsinki. Results will be published in peer-reviewed journals and presented at conferences.

Trial registration number

NCT05197972.

Ultrasound-guided serratus anterior plane block to prevent neurocognitive impairment in elderly patients after thoracoscopic lobectomy: protocol for a single-centre, double-blind, randomised controlled trial

Por: Wang · D.-Y. · Feng · D. · Liu · M.-Y. · Wu · W. · Xu · H. · Shi · H.
Introduction

Postoperative neurocognitive dysfunction (PND), including postoperative delirium (POD), is a common complication in elderly patients after major surgeries, often leading to poor postoperative recovery. Although the pathological mechanism underlying PND is still unclear, postoperative pain is strongly associated with the development of PND. The ultrasound-guided serratus anterior plane block (SAPB) has been reported to relieve postoperative pain in thoracic surgery. Therefore, this prospective trial hypothesises that SAPB may reduce the incidence of PND in the elderly undergoing thoracoscopic lobectomy.

Methods and analysis

This study is designed as a single-centre, double-blind, randomised controlled clinical trial. A total of 256 elderly patients scheduled to undergo thoracoscopic lobectomy at Shanghai Pulmonary Hospital will be randomly assigned to general anaesthesia group or SAPB group. The primary outcome is the incidence of PND 7 days postoperatively or before discharge from hospital. The secondary outcomes include the occurrence of POD, the postoperative pain scores, Quality of Recovery at 1–2 days postoperatively and incidence of PND at 3 months postoperatively. The levels of fasting blood glucose in peripheral blood will be examined before and 1–2 days postoperatively.

Ethics and dissemination

The trial has been approved by the Clinical Research Ethics Committee of Shanghai Pulmonary Hospital (identifier: K20-290). All participants will be required to provide written informed consent before any protocol-specific procedures. Findings will be disseminated in a peer-reviewed journal and in national and/or international meetings to guide future practice.

Trial registration number

ChiCTR2100052633.

Optimal concentration of ropivacaine for peripheral nerve blocks in adult patients: a protocol for systematic review and meta-analysis

Por: Li · J. · Pan · J. · Xu · Y. · Wang · Y. · Zhang · D. · Wei · Y.
Introduction

Ropivacaine is the most widely used local anaesthetic for peripheral nerve blocks (PNBs). The effects of various concentrations of ropivacaine in PNB have been investigated and compared by many randomised controlled trials (RCTs). This protocol aims to identify the optimal concentration of ropivacaine for PNB in adult patients.

Methods and analysis

PubMed, EMBASE, the Cochrane library and Web of Science will be searched from their inception to 10 July 2023. RCTs that compare the analgesic effects of different concentrations of ropivacaine for PNB will be included. Retrospective studies, meta-analyses, reviews, case reports, letters, conference abstracts and paediatric studies will be excluded. The duration of analgesia will be named as the primary outcome. Secondary outcomes will include the onset time of motor and sensory blockade, postoperative pain scores, analgesic requirements over 24 hours and the incidence of adverse effects. The study selection, data extraction and quality assessment will be performed by two independent reviewers. Data processing and analysis will be performed by RevMan 5.4. The quality of the evidence will be assessed by the Grading of Recommendations Assessment, Development and Evaluation approach.

Ethics and dissemination

Ethical approval is not applicable. The results of this study will be submitted to peer-reviewed journals.

PROSPERO registration number

CRD42023406362.

Pharmacological and non-pharmacological interventions to prevent delirium after cardiac surgery: a protocol for a systematic review and meta-analysis

Por: Cottuli de Cothi · E. · Perry · R. · Kota · R. · Walker-Smith · T. · Barnes · J. D. · Pufulete · M. · Gibbison · B.
Introduction

Delirium is a syndrome characterised by a disturbance in attention, awareness and cognition as a result of another physical condition. It occurs in up to 50% of patients after cardiac surgery and is associated with increased mortality, prolonged intensive care and hospital stay and long-term cognitive dysfunction. Identifying effective preventive interventions is important. We will therefore conduct a systematic review to identify all randomised controlled studies that have tested a pharmacological or non-pharmacological intervention to prevent delirium.

Methods and analysis

We will search electronic databases (CDSR (Reviews), CENTRAL (Trials), MEDLINE Ovid, Embase Ovid, PsycINFO Ovid) as well as trial registers (clinicaltrials.gov and ISCRTN) for randomised controlled trials of both pharmacological and non-pharmacological interventions designed to prevent delirium after cardiac surgery in adults. Screening of search results and data extraction from included articles will be performed by two independent reviewers using Rayyan. The primary outcome will be the incidence of delirium. Secondary outcomes include: duration of postoperative delirium, all-cause mortality, length of postoperative hospital and intensive care stay, postoperative neurological complications other than delirium, health-related quality of life and intervention-specific adverse events. Studies will be assessed for risk of bias using the Cochrane RoB2 tool. A narrative synthesis of all included studies will be presented and meta-analysis (if appropriate network meta-analysis) will be undertaken where there are sufficient studies (three or more) for pooling results. Results will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.

Ethics and dissemination

No ethical approval is required. This review will be disseminated via peer-reviewed manuscript and conferences.

PROSPERO registration number

CRD42022369068.

Effect of percutaneous cerebral oximetry-guided anaesthetic management on postoperative delirium in older adults undergoing off-pump coronary artery bypass grafting: study protocol for a single-centre prospective randomised controlled trial in a tertiary

Por: Tian · L. · Wang · H. · Jia · Y. · Jin · L. · Zhou · C. · Zhou · H. · Yuan · S.
Introduction

Postoperative delirium is a prominent and clinically important complication in older adults after coronary artery bypass grafting (CABG) surgery, resulting in prolonged hospital stay, long-term cognitive impairment and increased morbidity and mortality. Many studies have shown that cerebral desaturation is associated with increased risk of postoperative delirium during on-pump cardiac surgery. However, few studies have focused on the effect of optimising regional cerebral oxygen saturation (rSO2) on postoperative delirium during off-pump CABG. The purpose of this study is to investigate whether intraoperative anaesthetic management based on percutaneous cerebral oximetry monitoring decreases the incidence of postoperative delirium in older adults undergoing off-pump CABG.

Methods

This single-centre randomised controlled trial will randomly assign 200 patients to the intervention group or the control group at a ratio of 1:1. The patients in the intervention group will be observed by percutaneous cerebral oximetry monitoring that the desaturation (a drop of more than 20% from baseline value or rSO2 less than 55% for >60 consecutive seconds at either probe) during the procedure triggered the intervention strategies, while the cerebral oximetry data of the control group will be hidden from the clinical team and patients will be anaesthetised by the usual anaesthetic management. The primary outcome will be the incidence of postoperative delirium during the first 7 days after off-pump CABG. Delirium will be comprehensively evaluated by the combination of the Richmond Agitation Sedation Scale and the Confusion Assessment Method for the intensive care unit. The secondary outcomes will include the incidence of postoperative acute kidney injury and myocardial infarction during the hospital stay, as well as the intensive care unit and hospital length of stay.

Ethics and dissemination

This study was approved by the Ethics Committee of the Chinese Academy of Medical Sciences, Fuwai Hospital (No 2022–1824). Written informed consent will be obtained from each patient or their legal representatives before enrolment. The results of this trial will be published in an international peer-reviewed scientific journal.

Trial registration number

ChiCTR2300068537.

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