Processed electroencephalography (pEEG) monitoring is commonly employed to assess the level of hypnosis under anaesthesia, although it is susceptible to various non-brain-related artefacts. Several sources of artefacts have been published, but how these sources affect the pEEG and their related hypnotic indices have not been summarised before. This scoping review will summarise the published literature on how non-pharmacological artefacts affect pEEG monitoring during anaesthesia andintensive care, including their influence on the hypnotic index and the underlying mechanisms of interference.
Non-pharmacological, non-brain-related sources of artefacts affecting human patients under anaesthesia or intensive care will be included. The covered concepts include the sources of interference affecting pEEG in which the artefact causes the hypnotic index to no longer be reflective of the depth of hypnosis, how they affect the hypnotic index, and the suspected mechanism by which they affect the pEEG monitor. Databases to be searched will include PubMed, Ovid MEDLINE, Embase, Cochrane Library, CINAHL and the Web of Science. Grey literature will include sources from Google Scholar, the Web of Science, preprint repositories and reference lists of included studies and review papers. The search will be conducted on 19 June 2025, followed by a later repeat search for new articles once the data from the initial search have been extracted. The search will be limited to English articles. Search results will be imported into Covidence for screening. Data extraction will be conducted by two extractors independently, and the data will be summarised in tables.
There are no ethical or safety concerns associated with this study. Ethics approval was not obtained as this scoping review will summarise data from previously published sources, and the findings will be published in a peer-reviewed journal.
Postoperative pain is common, with approximately one-third of surgical patients experiencing severe acute pain and 10–20% developing chronic post-surgical pain (CPSP). Evidence shows that female patients are at higher risk of pain after sex non-specific surgery, thus sex- or gender-specific differences in pain treatment efficacy with potential consequences for perioperative pain management are to be expected. Considering the clinical and societal burden of poorly managed postoperative pain, the GEPard project comprises two systematic reviews, GEPard 1: sex- and/or gender-specific differences in efficacy of perioperative pain management for certain (major) surgical procedures in adult patients; and GEPard 2: sex- and/or gender-specific differences in the dosing, efficacy and adverse effects of the most common systemic perioperative non-opioid- and co-analgesics across all sex non-specific surgical procedures in adult patients.
The reviews will be conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and the Cochrane Handbook. MEDLINE, Embase, Cochrane Library, Web of Science, Scopus, ClinicalTrials.gov and PsycINFO will be searched. We will include randomised controlled trials (RCTs) and systematic reviews/meta-analyses reporting outcomes disaggregated by sex and/or gender in adult surgical patients. For GEPard 1, this applies to selected major surgical procedures; for GEPard 2, to all non-sex-specific surgical procedures. Interventions include regional anaesthesia, systemic analgesics and psychological strategies for GEPard 1 and non-opioid- as well as co-analgesics for GEPard 2. Two reviewers will independently screen and extract the data. Cochrane Risk of Bias Tool 2.0 (RoB 2) and AMSTAR 2 tools will assess study quality. Random-effects or Bayesian meta-analyses will be performed where possible; otherwise, narrative synthesis will be applied. GRADE methodology will assess evidence certainty.
No ethical approval is required for these reviews. Findings will be disseminated via peer-reviewed publications, patient organisations and professional societies. Data will be shared via Zenodo or Open Science Framework (OSF), following FAIR principles.
The systematic review protocols for both reviews have been registered in PROSPERO on 29 August 2025 (Registration-ID: CRD420251121393 (GEPard1), CRD420251121536 (GEPard2).
Although neurofilament light chain (NfL) is used as a biomarker of neurodegenerative decline, its application in surgery- and anaesthesia-induced acute cognitive dysfunction remains uncertain. We aimed to synthesise existing evidence to evaluate the potential of NfL as a biomarker for perioperative neurocognitive disorder (PND).
Systematic review and meta-analysis.
PubMed, EMBASE, MEDLINE, the Cochrane Library and the Cochrane Central Register of Clinical Trials were systematically searched up to March 2024.
Observational studies—including cohort, case-control and cross-sectional designs—were included if they reported cerebrospinal fluid (CSF) or blood NfL levels in individuals with and without PND.
Three independent reviewers assessed each article. Quality scoring was conducted, and the extracted data were analysed using STATA. Risk of bias was evaluated using the Newcastle–Ottawa Scale. Meta-analytical model selection was guided by the I2 statistic, with I2≤40% indicating low heterogeneity and the use of a fixed-effect model; random-effects models were used when this threshold was exceeded.
Within-group analyses showed significant postoperative increases in blood NfL levels in both the postoperative delirium (POD) group (standardised mean difference (SMD) = 0.49; 95% CI 0.34 to 0.64) and the no-POD group (SMD=0.67, 95% CI 0.53 to 0.81). Between-group comparisons revealed significantly higher preoperative CSF NfL levels in the POD group (SMD=0.27, 95% CI 0.07 to 0.47). Both preoperative and postoperative blood NfL levels were also significantly elevated in the POD group (SMD=0.53, 95% CI 0.40 to 0.66, and SMD=0.58, 95% CI 0.43 to 0.73, respectively).
This meta-analysis suggests that NfL may be a potential biomarker for POD. Further research is needed to clarify the association between CSF and blood NfL levels and other forms of PND.
CRD42024516907.
Current medications used for neonatal MRI sedation may lead to complications such as decreased oxygen saturation, apnoea and bradycardia. There has been no study investigating the application of midazolam oral solution in neonatal MRI examinations. Therefore, this study aims to observe the safety and efficacy of midazolam oral solution for sedation during neonatal MRI examinations, providing a reference for clinical application.
We designed a double-blind randomised controlled trial. A total of 140 neonates who underwent MRI are included. The neonates are randomly assigned into two groups of n=70 each to receive either midazolam oral solution or chloral hydrate oral solution. The primary outcome indicator of the study is the success rate of sedation as assessed by the University of Michigan Sedation Scale (UMSS). In addition, the time to a UMSS score of 2 or greater after drug administration, the number of sedation remedies, the behavioural scores of the children while taking the drug and the movement scores during the MRI performed are collected as secondary outcome indicators.
Ethical approval for the study was obtained from the Ethics Committee of the Chengdu Women’s and Children’s Central Hospital (Approval No. 2023 (18)–2). The study findings will be submitted for peer-reviewed publication in a scientific journal.
ChiCTR2300069996.
Poor cardiopulmonary fitness is an important risk factor for postoperative complications, yet a feasible, objective and prognostically accurate method to assess preoperative fitness has not been established. The 6 min walk test (6MWT) is a simple, inexpensive and widely applicable measure that shows promise for predicting postoperative risk. However, robust data are lacking on whether the 6MWT accurately predicts complications, provides incremental prognostic value beyond routinely collected clinical factors or outperforms simpler alternatives such as questionnaires, cardiac biomarkers or grip strength testing. The Functional Assessment for Surgery by a Timed Walk (FAST Walk) study is designed to address these knowledge gaps by evaluating whether the 6MWT improves prediction of key postoperative outcomes compared with clinical factors and simpler measures of fitness.
The FAST Walk study is an international multicentre prospective cohort study of 1672 adults (≥40 years) undergoing major elective non-cardiac surgery at centres in Canada, Hong Kong, Australia, Spain and the Netherlands. Participants complete a preoperative 6MWT and baseline assessments of comorbidities, self-reported cardiopulmonary fitness (MET: Re-evaluation for Perioperative Cardiac Risk questionnaire), biomarkers (N-terminal pro-B-type natriuretic peptide) and grip strength. The primary outcome is 30-day death or major postoperative complication, defined as Clavien-Dindo grade II or higher. Secondary outcomes are (1) death or new significant disability at 90 days after surgery and (2) days alive and out of hospital at 30 days after surgery. Disability is measured using the short-form WHO Disability Assessment Schedule 2.0 instrument. Multivariable regression models and complementary metrics of prediction performance will be used to determine whether 6MWT distance adds prognostic value beyond routinely collected clinical factors and simpler measures of fitness.
The FAST Walk study has received research ethics board approval at all participating sites. Recruitment commenced in June 2024, with completion of participant follow-up expected in 2026. Findings will be disseminated through peer-reviewed publications and conference presentations, with the primary results anticipated in 2027.
Persisting diaphragmatic dysfunction (DD) for more than 24 hours after thoracic surgery is associated with higher rates of pulmonary complications and prolonged intensive care unit stays. Despite advances in less invasive techniques, the incidence of DD remains significant, affecting ~55%–68% of patients after video-assisted thoracoscopic surgery (VATS). Non-intubated VATS (NIVATS) has gained popularity for its safety, but its impact on outcomes, particularly DD, remains unclear. We aim to determine the incidence of DD following NIVATS in adult patients.
The DYNASTY (Diaphragmatic dYsfunction after Non-intubated video ASsisted Thoracic surgerY) study is a prospective, single-centre, single-arm observational study including 100 adult patients undergoing NIVATS for minor elective thoracoscopic procedures. Diaphragmatic function is assessed using bedside ultrasound preoperatively (baseline) and at 2 and 24 hours postoperatively. The primary outcome is the incidence of DD at 24 hours (defined as diaphragmatic excursion ≤10 mm on quiet breathing). Secondary outcomes include the incidence of postoperative respiratory complications (eg, pneumonia, acute chronic obstructive pulmonary disease exacerbation) and their association with DD. Statistical analyses will estimate DD incidence with 95% CIs and employ multivariable logistic regression to identify predictors of DD, adjusting for potential confounders.
The study protocol was approved by an institutional ethics committee (ID 2024-A009121-45), and all participants will provide written informed consent. Results will be disseminated through peer-reviewed publications and conference presentations. De-identified data will be made available on reasonable request, and the trial registry will be updated with data availability in line with International Committee of Medical Journal Editors (ICMJE) recommendations.
Visual Patient Predictive (VPP) is an AI-based extension of the Visual Patient Avatar (VPA) that integrates deep learning models to predict upcoming vital sign deviations and display them as dashed visual elements. By explicitly showing anticipated changes, the system aims to support level 3 situation awareness—the projection of future patient states. This multicentre simulation study will evaluate whether predictive algorithms and visualisations integrated into the VPA (resulting in VPP) improve clinicians’ ability to anticipate critical vital sign changes compared with conventional number-based and waveform-based monitoring and examine its effects on decision-making, confidence, workload and user acceptance.
This investigator-initiated, randomised, within-subjects crossover, computer-based simulation trial will be conducted at five academic centres in Switzerland, Germany and the United States. Medical professionals from anaesthesiology departments will complete scenario-based prediction tasks using both VPP (as the index test) and conventional monitoring (as the reference standard) in randomised order, with the same participant evaluating both modalities and the identical underlying clinical scenario used in each condition, following video-based training and a learnability test. The primary outcome is recall (true positive rate) of vital sign deviation predictions. Secondary outcomes include average lead time, precision, prediction confidence, number and correctness of proposed interventions, perceived workload (NASA-TLX) and qualitative usability feedback. Quantitative data will be analysed using a logistic generalised linear mixed model with random intercepts for centre and participant, and a random slope for the intervention effect. Qualitative interviews will undergo thematic analysis.
The leading ethics committee (Zurich, Switzerland; BASEC-Req-2023–00465) reviewed and approved the study protocol. Ethics committees at the other participating centres have obtained their respective approvals or waivers. Bonn: 2025–144-BO, Boston: 2025P000501, Heidelberg: S-376/2025, Munich: 2025–357 W-CB. As this simulation study involves only healthcare professionals performing prediction tasks based on simulated vital sign scenarios—without collection of patient data or any medically relevant personal data—it does not constitute human subjects research under applicable regulations. Study results will be disseminated through peer-reviewed publications and presentations at scientific conferences.
Postoperative sore throat and hoarseness are common complications following lung isolation with double-lumen tubes (DLTs) in video-assisted thoracoscopic surgery (VATS). Laryngeal mask airway (LMA) combined with a visual bronchial blocker (VBB) may reduce airway trauma while maintaining effective lung isolation.
This is a prospective, randomised, controlled, single-blind, multicentre clinical trial conducted at three major thoracic surgery centres in Shanghai, China. A total of 270 patients aged ≥18 years scheduled for elective VATS anatomical lung resection will be randomly allocated 1:1 to either the VBB group (n=135) using LMA combined with VBB or the DLT group (n=135) using conventional DLT (see Consolidated Standards of Reporting Trials diagram). The primary outcome is the incidence of sore throat and hoarseness at 24 hours postoperatively. Secondary outcomes include sore throat and hoarseness at 1 and 48 hours, intraoperative device performance, lung collapse quality, intubation time, haemodynamic changes, emergence quality, device-related complications and hospital length of stay.
The study protocol was approved by the Ethics Committee of Shanghai Chest Hospital (KS24042). Results will be disseminated through peer-reviewed publications and conference presentations.
ClinicalTrials.gov (NCT07117539).
Implantable neuromodulation therapies are offered to patients with certain refractory pain syndromes. These therapies are resource-intensive and effort-intensive and may be associated with significant adverse effects. Change in pain intensity score, an unidimensional measurement tool, is currently the most used eligibility criteria for patients to receive implanted neuromodulation devices. However, pain is a biopsychosocial phenomenon, and assessment of effectiveness of neuromodulation therapies using tools that incorporate multiple pain-related domains may be more relevant and accurate. Composite measures integrate multiple domains of patient well-being, enabling a clinically relevant assessment of treatment effects. This systematic review aims to evaluate the literature on the clinical utility and reliability of composite outcomes as a means to assess efficacy of implantable neuromodulation therapies for refractory pain.
We will search Embase, MEDLINE, Cochrane Central Register of Controlled Trials and the WHO’s International Clinical Trials Registry Platform. Searches will be limited to from inception of each database to 31 December 2025. Studies published in English will be considered eligible if they used composite outcomes to evaluate the efficacy and/or effectiveness of implantable neuromodulation therapies for treating refractory pain. The studies should investigate adult populations (aged ≥18 years) undergoing implantation for chronic refractory pain of moderate-to-severe intensity. Two reviewers will independently screen articles, extract data and review the risk of bias and the grade of evidence provided in the studies. Extracted data will include study details (author, year, country of origin), participant demographics (age, sex), sample sizes and intervention details. Outcome measures include pain intensity, physical health, mental health, quality of life, medication use and neuromodulation device explantation rates. Data will be collected at baseline, 3 months, 6 months and 12 months post-implantation where available. A meta-analysis will be formed if there is sufficient homogeneity in the studies and their data.
As this study is a systematic review using data that has already been published in scientific literature or is publicly available, ethics approval is not required. For dissemination, we plan to share the findings of our review through multiple academic and clinical channels. The completed review will be submitted for publication in a peer-reviewed journal relevant to pain medicine or neuromodulation.
CRD42025631488.
Circadian rhythm disturbance is associated with neurologic, metabolic, cardiovascular and immune disorders. As the most reliable biomarker of endogenous circadian rhythms, melatonin regulates the sleep-wake cycle and promotes sleep. Studies have demonstrated that saliva and plasma melatonin levels show strong correlations in non-surgical populations. However, the relationship between salivary and plasma melatonin measurements in patients undergoing surgery is unknown. This study will analyse the correlation between the peak concentrations of salivary and blood melatonin in perioperative patients.
In this prospective study, 102 patients scheduled for thoracic or neurosurgical procedures are being enrolled. The primary outcome of this study is to analyse the correlation between the peak concentrations of salivary and plasma melatonin (measured at 04:00 on the first postoperative day) in patients.
The study protocol has been approved by the Medical Ethics Committee of Peking University Third Hospital (M2023009). The results of the study will be published in peer-reviewed international journals.
The study has been registered at the Chinese Clinical Trial Registry (www.chictr.org.cn) with identifier ChiCTR2300070470. The latest version of the trial protocol was approved in October 2023.
Today, arterial blood gas (ABG) testing is widely used in various hospital departments to support diagnosing diseases and predicting patient conditions. However, interpreting the numerical results of this test, its complex concepts continue to pose challenges for nurses and physicians. Therefore, the use of innovative educational approaches can simplify the learning of ABG interpretation. Two educational approaches that have recently received attention are the Flipped classroom and Microlearning. To evaluate and compare these approaches, we will develop a comprehensive evaluation protocol based on Kirkpatrick’s model.
This study is a quasi-experimental design that will involve 188 undergraduate nurse anaesthesia students at Tehran University of Medical Sciences, randomly allocated to a flipped classroom or microlearning groups (94 per group). The intervention will consist of one session for all registered students and three sessions for each group with their own educational approach. Two sets of educational content, according to each approach method, will be developed based on a needs assessment and will be shared via secure social media. The flipped classroom group will receive pre-session materials, followed by in-person classes. The microlearning group will engage in in-person sessions supported by micro videos, podcasts and micro games delivered via Telegram. Effectiveness will be evaluated by using Kirkpatrick’s four-level model. 1 week after the intervention concludes, participants will be invited to a meeting to complete the Training Satisfaction Rating scale (Level 1, Reaction). We will use a pre-test and a post-test for evaluating Level 2 (Learning). Level 3 (Behaviour) will be evaluated through observations of ABG interpretation at internship sites. Level 4 (Results) will be evaluated via semi-structured interviews with specialists and colleagues. Data will be analysed blind; normality will be assessed (Kolmogorov-Smirnov test), and appropriate statistical tests (t-tests, ANCOVA, 2 or Fisher’s exact) will be applied.
This study received permission and ethical approval from Tehran University of Medical Sciences (IR.TUMS.SPH.REC.1404.08). Since the study is not clinical, obtaining a trial registration number is not required under Iranian research policy, and an ethical approval alone is sufficient. Informed consent will be obtained before participants are enrolled. The study’s results will ultimately be submitted as a research paper to a peer-reviewed journal.
Perioperative psychological symptoms are prevalent among patients undergoing lung surgery and can contribute to adverse clinical outcomes. Pharmacological interventions for these symptoms have inherent limitations. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a promising non-invasive therapeutic approach. This study aims to evaluate the efficacy of taVNS in managing perioperative psychological symptoms in patients undergoing elective thoracoscopic pneumonectomy under general anaesthesia.
This single-centre, prospective, randomised, double-blind, controlled trial will enrol 176 patients scheduled for elective thoracoscopic lung resection. Participants will be randomly allocated to either the active taVNS or the sham taVNS groups in a 1:1 ratio. Both groups will receive 30 min active or sham stimulation sessions at four time points: (1) the afternoon prior to surgery, (2) the morning of the surgery, (3) following extubation and (4) the first afternoon postsurgery. The primary outcome is the incidence of perioperative anxiety, assessed using the Hospital Anxiety and Depression Scale-Anxiety subscale. Secondary outcomes include depression scores, stress index, sleep quality, pain scores, incidence of postoperative delirium, fatigue, cough symptoms and postoperative recovery quality, all evaluated through validated assessment tools. Analyses will be conducted using intention-to-treat and per-protocol populations.
The Ethics Committee of Affiliated Hospital of Xuzhou Medical University granted approval for the study with approval number: XYFY2024-KL444-01. Dissemination will be via national anaesthesia conferences and publication in the peer-reviewed literature.
ChiCTR2400090542.
Postictal agitation (PIA) is a common adverse effect following electroconvulsive therapy (ECT). Current pharmacological treatments for PIA have undesirable side effects, and interventions to prevent PIA are unsatisfactory. The aim of this study is to assess the effect of peri-interventional music on PIA for patients undergoing ECT. Additionally, the study will assess the impact of music on pretreatment anxiety and post-treatment cognitive impairment.
This multicentre, open-label, parallel randomised controlled trial (RCT) aims to include 92 patients from two centres in Rotterdam, the Netherlands. Participants will be randomised into two groups: a music intervention group and a control group. The music group listens to recorded music 30 min before and 12 min after each of the first six ECT sessions of the full ECT course, while the control group will receive standard care. The primary outcome is the presence of PIA, measured using the Richmond Agitation-Sedation Scale (RASS). Secondary outcomes include the severity and duration of PIA, pretreatment anxiety, recovery duration, peri-treatment medication requirements, cognitive impairment and depression severity. Data will be analysed according to an intention-to-treat principle.
This study protocol has been approved by the Medical Ethical Review Committee of the Erasmus Medical Centre on 28 January 2025 (MEC-2024–0467) and subsequently received local approval at Antes Parnassia group. The trial will be carried out following the Declaration of Helsinki principles. Study results will be reported in a peer-reviewed journal according to the Consolidated Standards of Reporting Trials guidelines.
Perioperative sleep disturbance (PSD) can adversely affect immunological and cognitive functions, can prolong hospital stays and have long-lasting effects on quality of life, ultimately increasing mortality rates. Unfortunately, PSD is common among surgical patients and can manifest at any stage during surgical care with a high incidence. Owing to the high incidence and severe adverse outcomes of PSD, effective management of PSD is imperative in clinical practice. Intranasal administration of dexmedetomidine is a safe and effective strategy for improving perioperative sleep quality. It is characterised by high bioavailability, a low incidence of adverse events and the avoidance of pain from venipuncture and intramuscular injection. However, this clinical evidence is insufficient due to the limited sample size, diverse outcome observation indicators and inconsistent research quality. Consequently, we will conduct a protocol for a systematic review and meta-analysis to offer clinical evidence on whether intranasal dexmedetomidine can be opted as an effective treatment for PSD.
English databases (PubMed, Web of Science, Ovid Medline, Embase and Cochrane Library), Chinese electronic databases (Wanfang database, VIP Database and China National Knowledge Infrastructure) and clinical trial registry platforms will be screened from their inception up to October 2025 to detect randomised controlled trials of intranasal dexmedetomidine for the management of PSD. We will compute the mean differences (MDs) or standardised MDs along with 95% CIs for continuous data, and the risk ratio with 95% CIs for dichotomous data using Review Manager V.5.4. Either the fixed-effects or random-effects model will be employed depending on the heterogeneity assessed by Cochran’s Q test and the I2 statistic. Risk of bias will be assessed by Cochrane risk-of-bias tool V.2, while evidence quality will be evaluated by the Grading of Recommendations Assessment, Development and Evaluation approach. The conclusiveness of evidence will be evaluated via trial sequential analysis. Moreover, publication bias will be assessed via funnel plot analysis supplemented with Egger’s regression test.
Ethical approval was not required for this systematic review protocol. The results will be disseminated through peer-reviewed publications.
CRD420251002119.
Emergence agitation (EA), defined as acute postoperative restlessness after general anaesthesia, is a common complication in the post-anaesthesia care unit (PACU). The reported incidence of EA is nearly 30% in neurosurgical surgery, which bears tremendous risks for neurosurgical patients. Although current evidence suggests that remifentanil may reduce EA risk in non-cardiac settings, its preventive efficacy in patients undergoing intracranial surgery remains unclear.
In this single-centre, randomised, double-blind, parallel-group prospective clinical trial, patients scheduled for elective craniotomy will be screened to confirm their eligibility. After surgery under general anaesthesia, patients will be assigned to groups to receive either remifentanil or placebo infusion on admission to the PACU. The remifentanil group will be given remifentanil infusion at a dose of 0.1 µg/(kgxmin), whereas the control group will be given the same volume of normal saline. The primary outcome is the effect of remifentanil on EA incidence during the emergence period. Secondary outcomes include the following: time to regain consciousness, extubation time, total PACU duration, extubation comfort score measured by the modified Minogue Scale, postoperative pain intensity assessed using a Numerical Rating Scale, awakening quality and postoperative delirium assessed by alertness and orientation score, and a 3-Minute Diagnostic Interview for Confusion Assessment Method.
The study protocol (V.4.0, dated 14 August 2025, No. 2025–0954) has been approved by the Institutional Ethics Committee of the First Affiliated Hospital, Zhejiang University School of Medicine and complies with the Declaration of Helsinki and relevant regulations for research involving human participants. Findings will be disseminated through peer-reviewed publications and conference presentations.
ChiCTR2500096691.
For ovarian cancer patients undergoing preoperative Neoadjuvant Chemotherapy (NACT), the toxicity of chemotherapeutic agents may cause hepatic and renal function impairment, altered sensitivity of the central nervous system or abnormal pain perception thresholds. These changes can further affect the metabolism and efficacy of intraoperative anaesthetics. However, the optimal intraoperative opioid dosage regimen for this specific patient population remains unclear. Currently, nociceptive stimulation monitoring technology has achieved certain progress in guiding intraoperative opioid administration. Among this technology, the index of consciousness 2 (IOC2), as a representative monitoring indicator in this field, provides important references for optimising opioid dosage regimens. This trial will investigate the opioid requirements and patient outcomes in the anaesthetic management of ovarian cancer patients undergoing preoperative NACT guided by IOC2.
This prospective, single-blind, single-centre randomised controlled trial will randomly recruit 90 patients undergoing open ovarian cancer cytoreductive surgery under general anaesthesia, with equal numbers assigned to the control and experimental groups. The experimental group will adjust the remifentanil plasma target concentration based on the IOC2 value, while the control group will adjust according to the patients’ mean arterial pressure. The primary outcome will be intraoperative opioid use (calculated in morphine equivalents per hour). Secondary outcomes include the average intraoperative propofol dose, post-anaesthesia care unit (PACU)-related metrics (including extubation time, time to spontaneous eye opening and morphine consumption in PACU), pain levels at 4, 24 and 48 hours postoperatively, as well as the use of analgesics and antiemetics. Postoperative recovery quality will also be assessed, including time to first flatus, time to ambulation, length of hospital stay and the 24-hour Quality of Recovery-15 (QoR-15) score.
This study involves human participants and was approved by the Ethics Committee of the Jiangsu Cancer Hospital (ethics no: XJS-2024-017). Patients gave informed consent to participate in the study before taking part. The study results will be published in peer-reviewed journals and presented at relevant academic conferences.
ChiCTR2400091897.
Previous studies have indicated that exposure to anaesthetics has potential neurotoxic effects, particularly in cases of multiple and long-term general anaesthesia. However, there is currently no research exploring the relationship between early anaesthesia and neurological development in children with congenital scoliosis, who may require multiple surgical treatments. Herein, we present our design for a prospective longitudinal observational cohort study, assessing the long-term impact of general anaesthesia for surgery before school age on neurocognitive function and behaviour in children with congenital scoliosis.
A dynamic cohort of children aged 6–16 years diagnosed with congenital scoliosis between July 2020 and December 2025 in the Department of Orthopaedic Surgery at a tertiary hospital will be enrolled, with an aim to include 150 patients. Detailed information about baseline characteristics, previous anaesthesia and surgery will be collected from medical records, parents or guardians. Neurodevelopment will be evaluated using the abbreviated version of the Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV) for neurocognition, and parent-report Achenbach Child Behaviour Checklist and Strengths and Difficulties Questionnaire for neurobehaviour. Repeated measures will be performed during follow-up, with at least a 1-year interval from the previous assessment, whenever the participants are available. The primary outcome is the full-scale intelligence quotient estimated by the WISC-IV. A linear mixed effects model will be constructed, with exposure group—categorised as none, single or multiple anaesthesia exposures based on all episodes of general anaesthesia for surgery before the age of 7 years—as a fixed effect and subject-specific random effects intercept.
The study was approved by the Institutional Review Board of Peking Union Medical College Hospital (S-K1093). Written informed consents will be obtained from the parents or guardians. The results of this research will be disseminated through peer-reviewed publications and conference presentations, and shared with paediatric surgical patients and their families who are concerned about the potential neurotoxicity of anaesthesia in clinical practice.
Dexamethasone is commonly used to prevent postoperative nausea and vomiting (PONV). However, PONV is an unresolved complex problem; even with preoperative dexamethasone administration, 14.0%–26.3% of patients undergoing minimally invasive endoscopic procedures still experience PONV within 24 hours postoperatively. Compared with dexamethasone, dexamethasone palmitate has a long-lasting anti-inflammatory effect, two to five times that of traditional water-soluble dexamethasone, with fewer adverse events. This trial aims to assess the efficacy and safety of preoperative dexamethasone palmitate administration on postoperative PONV.
The INDEX trial is a multicentre, open-label, randomised, positive-controlled trial. A total of 588 patients will be recruited from three centres in China. Eligible patients are adults (aged 18–65 years) who undergo elective minimally invasive endoscopic surgery (laparoscopic or thoracoscopic surgery) under general anaesthesia. Eligible patients will be randomly assigned (1:1) to the dexamethasone palmitate or dexamethasone group. Patients in the dexamethasone palmitate group will receive intravenous injection of 8 mg of dexamethasone palmitate (containing 5 mg of dexamethasone), and those in the dexamethasone group will receive 5 mg of dexamethasone after anaesthesia induction and before surgical incision. The primary endpoint will be the incidence of PONV within the first 24 hours postoperatively. Secondary outcomes will include the incidence of PONV, postoperative nausea, postoperative vomiting, number of vomiting or retching episodes, severity of PONV, participant satisfaction, use of rescue antiemetic drugs and quality of postoperative recovery. The safety of participants will be monitored. A primary analysis will be conducted to evaluate between-group differences in the incidence of PONV in the intention-to-treat population and within the first 24 hours postoperatively. We will also perform a sensitivity analysis to evaluate the effect of missing values in the outcome parameters on the results. There is no plan to conduct an interim analysis.
Ethical approval was obtained from the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (KY 2025-041-02-01). The results will be disseminated in open-access publications and plain-language summaries.
Post-induction hypotension (PIH) is a critical concern in elderly surgical patients and is associated with adverse postoperative outcomes. This trial aims to compare the effects of propofol, etomidate and remimazolam on the incidence of PIH in older adults undergoing non-cardiac surgery.
In this single-centre, triple-arm, randomised controlled trial, 210 patients aged ≥80 years with American Society of Anaesthesiologists physical status I–III undergoing elective non-cardiac surgery will be recruited. All patients will receive general anaesthesia with endotracheal intubation. Patients will be randomised (1:1:1) to receive propofol, remimazolam or etomidate for anaesthesia induction (n=70 per group). The primary outcome is the incidence of PIH (mean arterial pressure (MAP) 30% from baseline, vasopressor requirements, bradycardia, injection pain, myoclonus, postoperative delirium, and cardiac, cerebral and renal complications during hospitalisation.
This trial was approved by the Ethics Committee of the First Affiliated Hospital of Soochow University (Approval No. 2024-380). The results will be peer-reviewed for publication in a scientific journal.
ChiCTR2400090800.
Postoperative ileus (POI) is a common complication after abdominal surgery that significantly delays recovery. Evidence suggests that the general anaesthetic propofol inhibits gastrointestinal motility, potentially contributing to POI. Ciprofol, a newer general anaesthetic characterised by the addition of a cyclopropyl group to the propofol structure, has uncertain effects on gastrointestinal recovery. This randomised trial aimed to evaluate the effect of ciprofol compared with propofol on gastrointestinal function in patients undergoing laparoscopic colorectal cancer resection.
This prospective, single-centre, single-blinded, randomised controlled trial will enrol patients aged 18–65 years undergoing laparoscopic radical resection for colorectal cancer. A total of 176 participants will be randomly assigned to either the ciprofol group (experimental) or the propofol group (control), with 88 patients in each arm. General anaesthesia will be induced and maintained with ciprofol in the experimental group or propofol in the control group. The primary outcome is the time to first postoperative flatus. Secondary outcomes include key parameters associated with enhanced recovery after surgery. Patients will be followed at baseline and every 24 hours postoperatively.
The study protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Xi’an Jiaotong University (XJTUAF2024LSYY-415–03). Results will be published in peer-reviewed journals and presented at scientific conferences.
ChiCTR2400093434.