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.

NCT06817330.

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.

NCT06315933.

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.

NCT06981754

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.

Epidural analgesia-related maternal fever (ERMF) affects 15%–25% of parturients, posing risks to both maternal and neonatal. Although ERMF’s mechanisms remain unclear, non-infectious inflammatory responses and thermoregulatory disruption are implicated. Previous studies suggest that room-temperature local anaesthetic solutions administered during epidural analgesia may contribute to ERMF by altering spinal thermoregulation. This trial investigates whether warming local anaesthetic solutions to body temperature reduces ERMF incidence.

This two-centre, double-blind, randomised controlled trial will enrol 424 parturients undergoing epidural analgesia for trial of labour. Participants will be randomised (1:1) to receive either body temperature (approximately 37°C) or room temperature (approximately 23°C) local anaesthetic solutions (0.1% ropivacaine with 0.5 µg/mL sufentanil). The primary outcome is intrapartum fever incidence, defined as oral temperature ≥38°C. Secondary outcomes include time to visual analogue scale ≤3, pulse perfusion index, maternal and neonatal antibiotic use rate, incidence of bacteraemia, intrapartum hypothermia, duration of labour, unplanned caesarean section rate, umbilical artery potential of hydrogen and Apgar scores at 1 and 5 min for newborns. Randomisation, stratified by study centre, employs permuted blocks via R software. Blinding is maintained for participants, outcome assessors and statisticians. A sample size of 424 participants (212 per group) provides 80% power (α=0.05) to detect a reduction in fever incidence from 21% to 10%. The primary analysis will be conducted in accordance with the intention-to-treat principle, with a secondary per-protocol analysis.

The study protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Soochow University (Approval No. 2023367-2) and the Ethics Committee of Suzhou Municipal Hospital (Approval No. K-2024-258 K01), and adheres to the Declaration of Helsinki. All participants will provide written informed consent. Results will be disseminated through peer-reviewed journals.

NCT06682416.

Intraoperative anaesthesia handoffs represent a risk point in the care of surgical patients. Although often necessary to prevent fatigue, improve vigilance and optimise operational efficiency, critical information can be lost, potentially leading to postoperative complications. Structured handoffs can increase the transfer of knowledge during intraoperative anaesthesia handoffs, improving their quality. We therefore propose to test the primary hypothesis that a semi-structured intraoperative anaesthesia handoff cognitive aid reduces the number of serious 30-day complications in surgical patients.

We will enrol adults having non-cardiac surgery who are scheduled to have an intraoperative anaesthesia handoff for operational reasons. We plan a cluster randomised trial (enrolling over 18 months, anticipated sample size approximately 4500 patients) that will compare the Epic Electronic Health Record intraoperative anaesthesia handoff cognitive aid to routine handoffs. Our primary outcome will be the number of serious postoperative complications within 30 days. Our secondary outcomes will be: (1) the number of minor complications; and (2) the duration of postoperative hospitalisation. Bayesian analysis with generalised linear multilevel modelling will be used to estimate the effect of structured handoffs on the primary and secondary outcomes.

This study has been approved by the local institutional review board with a waiver of informed consent. Results will be disseminated in the medical literature with de-identified data available on request.

NCT06533111.

Postoperative pulmonary complications (PPCs) are common after cardiac surgery and are associated with significant morbidity and mortality. Lung-protective ventilation strategies have been proposed to reduce PPCs, but the optimal level of positive end-expiratory pressure (PEEP) and the use of alveolar recruitment manoeuvres (RMs) remain controversial.

In this investigator-initiated, multicentre, open, randomised, parallel-group, superiority clinical trial, elective cardiac surgery patients at risk of PPCs will be assigned to one of two intraoperative ventilation strategies: (1) an open-lung ventilation strategy with protective ventilation, moderate PEEP and RMs or (2) a standard protective ventilation with low PEEP and no RM. The primary outcome will be a composite of prolonged (>24 hour) postoperative mechanical ventilation, reintubation for any cause or hospital-acquired pneumonia within 7 days of surgery, or death within 28 days of surgery. Data will be analysed on an intention-to-treat basis.

The VACARM (impact of intraoperatiVe moderAte positive end-expiratory pressure with reCruitment mAnoeuvres versus low positive end-expiRatory pressure on major postoperative pulMonary complications and death after on-pump cardiac surgery in high-risk patients) trial has been approved by an independent ethics committee for all study centres. Recruitment began in July 2021. Results will be published in international peer-reviewed medical journals.

ClinicalTrials.gov NCT04408495.

The hyperactivity of the sympathetic nervous system after a traumatic event contributes to the development of post-traumatic stress disorder (PTSD). Polarised light stellate ganglion irradiation (PLSGI) is a non-invasive and effective physiotherapy method for regulating the sympathetic nervous system. This study aims to investigate the effects of perioperative PLSGI on PTSD and pain-related outcomes in patients undergoing emergency surgery.

This multicentre, randomised, double-blind, controlled trial will include 510 adult patients scheduled for emergency trauma surgery. Patients will be randomly assigned in a 1:1 ratio, stratified by anaesthesia type (propofol general anaesthesia or other anaesthesia), to either the PLSGI group or the control group. The PLSGI group will receive perioperative PLSGI, while the control group will receive a sham PLSGI procedure. All patients will receive multimodal analgesia, consisting of intraoperative flurbiprofen axetil, ropivacaine infiltration at the end of surgery and postoperative patient-controlled sufentanil. The primary outcome is the incidence of PTSD 1 month postoperatively. Secondary outcomes include the severity of PTSD, delayed-onset PTSD, four symptom clusters (intrusive re-experiencing symptoms, avoidance symptoms, negative alterations in cognition or mood symptoms, and hyperarousal and reactivity symptoms), severity of dissociative symptoms, the amount of emergency postoperative analgesia, heart rate variability, sleep quality, anxiety, chronic pain, postoperative opioid use (sufentanil consumption) and need for rescue analgesia. Safety outcomes include hypotension, bradycardia, hypertension, tachycardia, interventions for haemodynamic events, malignant arrhythmias, hoarseness, localised allergy or burning pain, dyspnoea and coughing while drinking. All analyses will be conducted in the modified intention-to-treat population.

Ethical approval was obtained from the Ethics Committee of Xuzhou Central Hospital (XZXY-LK-20210129-2023040), the Ethics Committee of Suzhou Xiangcheng People’s Hospital (2023-KY-02) and the Ethics Committee of Xuzhou Renci Hospital (XZRCLL-KT-202302001). All patients will provide written informed consent. The results of this study will be published in a peer-reviewed journal.

ChiCTR2300070852.

Effective management of postoperative pain is essential for enhancing recovery and improving patient satisfaction after breast surgery. Traditionally, bupivacaine, a long-acting local anaesthetic, has been widely employed for this purpose. More recently, liposomal bupivacaine, a novel prolonged-release formulation, has been introduced as a potential alternative. Although several randomised controlled trials (RCTs) have evaluated these agents, their comparative efficacy remains uncertain. This protocol describes the methodology for a systematic review and meta-analysis designed to assess the analgesic effectiveness of conventional bupivacaine versus liposomal bupivacaine in the setting of breast surgery.

This study is designed as a systematic review and meta-analysis. A comprehensive literature search will be conducted in PubMed, Web of Science, Embase via Ovid, Medline via Ovid and the Cochrane Central Register of Controlled Trials to identify eligible RCTs up to the present date. The search strategy will combine relevant keywords and Medical Subject Headings terms related to bupivacaine, liposomal bupivacaine, breast surgery and pain management. Eligible studies will include RCTs enrolling adult patients (≥18 years) undergoing breast surgery. The interventions of interest are liposomal versus standard bupivacaine, typically administered perioperatively—most commonly intraoperatively via local infiltration or regional block—within the context of surgery under general anaesthesia. The primary outcome is the intensity of postoperative pain within 72 hours. Two reviewers will independently screen studies, extract data and assess risk of bias using the Cochrane Collaboration’s tool. Data will be synthesised using either a random-effects or fixed-effects model, with effect sizes reported as mean differences with 95% CIs for continuous outcomes, and risk ratios for dichotomous outcomes. Subgroup analysis, sensitivity analysis and assessment of publication bias will also be performed to ensure the robustness of findings.

Ethical approval is not required as only published data will be analysed. The meta-analysis findings will be published in a peer-reviewed journal and presented at relevant scientific conferences.

CRD42023451411.

Postoperative delirium (POD) is a common postoperative complex syndrome in older patients, which can lead to prolonged hospital stay, increased mortality and long-term cognitive decline as well as severely affect the prognosis and survival of affected individuals. Currently, the identification of POD mostly depends on clinical observation and scale measurement, which have limitations such as strong subjectivity and long assessment time. Therefore, screening for objective and effective detection indicators is crucial. This study will employ transcranial Doppler ultrasound (TCD) to collect preoperative middle cerebral artery (MCA) flow parameters to evaluate their correlations with POD, which may serve as an objective basis for evaluating POD. These findings may aid in the early identification of high-risk patients and provide a scientific basis for the early intervention and treatment of POD.

This study is a prospective, observational cohort investigation. Preoperative assessment, including patient baseline data, laboratory blood tests, TCD examination and cognitive evaluation, as well as obtaining informed consent, will be completed the day before surgery. The following patient data will be recorded: age, gender, body mass index, educational background, comorbidities, Mini-Mental State Examination score, American Society of Anesthesiologists grade, surgery duration, preoperative laboratory blood tests and MCA flow parameters. The primary endpoint measure is the incidence of POD, which will be assessed using the 3-Minute Diagnostic Interview for Confusion Assessment Method scale during a postoperative evaluation period of 7 days. The secondary endpoint is the POD typing, POD severity and occurrence of postoperative adverse events. This study aims to enrol 250 patients. Univariate and multivariate logistic regression analyses will be conducted to explore the factors associated with POD. The cut-off value obtained using the receiver operating characteristic curve will be used to evaluate the diagnostic value of individual or combined indexes.

This study was approved by the Ethics Committee of the Affiliated Hospital of Jiaxing University (2025-KY-108–003). All patients in this study will provide written informed consent. The study results will be published in an open-access format. This study does not include an independent data monitoring committee because it is an observational and low-risk investigation.

ChiCTR2500098949.

Frailty is a key predictor of adverse surgical outcomes in older adults, contributing to increased postoperative complications, prolonged hospitalisation and delayed recovery. Prehabilitation—targeting improvements in physical function before surgery—can mitigate these risks. However, traditional programmes often face low adherence due to logistical barriers. Integrating smart wearable devices into tele-supervised, home-based prehabilitation may enhance adherence, engagement and clinical outcomes.

This trial protocol describes the PREhabilitation of frail elderly PAtients undergoing majoR surgEry at HOME study with the objective to evaluate the effectiveness of a wearable-enhanced, tele-supervised prehabilitation programme (swSEP) versus standard care (unsupervised prehabilitation, uSEP) on improving preoperative functional capacity and postoperative outcomes in frail older adults undergoing major elective surgery.

This single-centre, prospective, randomised controlled trial will enrol 190 patients aged ≥65 years scheduled for major elective, non-cardiac surgery at Singapore General Hospital. Participants with frailty (Edmonton Frail Scale ≥6) will be randomised 1:1 to either the swSEP group (tele-supervised exercise with Fitbit Inspire 3 monitoring) or the uSEP group (standard physiotherapy education, exercise booklet and inspiratory muscle training if maximal inspiratory pressure 2O). The primary outcome is change in 6 min walk test distance from baseline to 1–3 days presurgery. Secondary outcomes include 30 s sit-to-stand test, handgrip strength, postoperative complications (per American College of Surgeons National Surgical Quality Improvement Program), hospital length of stay, readmissions, five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) and adherence. Data will be analysed using t-tests, analysis of covariance, logistic regression and Cox models, with stratification by baseline nutritional status.

Approved by the SingHealth Institutional Review Board (CIRB Ref: 2024/2242). Trial registered on ClinicalTrials.gov (NCT06633614). Results will be disseminated via peer-reviewed publications and academic conferences. Contact: irb@singhealth.com.sg

ClinicalTrials.gov Identifier: NCT06633614

The purpose of the study is to construct a postoperative nausea and vomiting (PONV) risk prediction model for day-case laparoscopic cholecystectomy (LC) using a machine learning combination algorithm and evaluate its performance.

A retrospective cohort study.

The Hospital Information System (HIS) and the Surgical Anaesthesia Information Management System (SAIMS).

Patient data are collected from the day surgery ward of Sichuan Provincial People’s Hospital from February 2023 to April 2024. The research subjects are adult patients (18–75) who underwent day-case LC, excluding patients with unexpected termination of the day surgery plan, such as the patient who was transferred to hepatobiliary surgery due to intraoperative conversion to laparotomy.

The study employed two data filling methods, two data sampling methods, two variable screening methods and six machine learning algorithms to construct 48 predictive models. Area under curve (AUC), accuracy, precision, recall rate and F1 value were used to evaluate the predictive performance of the model. The AUC of the test set is mainly used to evaluate the prediction performance, and the Shapley weighted explanatory value is used to determine the weight of the variable’s prediction contribution. We will collect patient data from this unit in July 2025 to evaluate the model’s performance.

A total of 2709 patients were selected for model construction in the study. 20 input variables were retained for developing the predictive model. The combined model of KNN, BSMOTE, RFEL and GBM shows the best AUC performance (0.9600). The five most important variables in the prediction model were postoperative pain, LESS method, citraturia dosage, gender and sufentanil dosage. An additional 211 patients were collected to validate the model performance with an AUC of 0.79.

The study finds that postoperative pain, LESS method and cisatracurium dosage are closely related to the occurrence of PONV in day-case LC. However, these three variables have rarely been reported in the previous literature and worth further research. The prediction model obtained in this study provides a meaningful reference for the perioperative prevention and treatment of PONV in day surgery.

In high-income countries, the prevalence of frailty ranges from 10% to 37%. However, data from low- and middle-income countries remain largely unavailable, and no information is currently available on the prevalence of frailty or cognitive impairment in the Georgian population. Preoperative frailty is a known risk factor for postoperative delirium and neurocognitive disorders, which can be life-threatening in the population of older adults.

This protocol describes a prospective, single-centre observational cohort study investigating preoperative frailty and postoperative neurocognitive disorders in older adults presenting for surgery in Georgia. The study will include 230 participants. Patients will be enroled after their cognitive health is evaluated using the Montreal Cognitive Assessment test. Frailty and neuropsychological tests are conducted at baseline, discharge, 30 days, 3 months and 12 months postoperatively. Additionally, IL-6 levels are measured in blood samples to assess systemic inflammatory levels preoperatively. Participants will be followed up for 1 year.

Our trial has been approved by the Ethics Committee of the LTD ‘New Hospitals’ clinic (Approval No. 23/01). Patient recruitment began in April 2023 in Tbilisi, Georgia, and will continue until 2026. Dissemination plans include presentations at scientific conferences, publication in peer-reviewed journals, engagement with stakeholders and outreach through popular media.

NCT06700291.

Effective postoperative pain management is a critical component of surgical care, directly influencing patient recovery, satisfaction and long-term outcomes. Despite recent advances in pain management, postoperative pain remains poorly managed worldwide, suggesting that postoperative pain outcomes are influenced by factors beyond the inherent efficacy of available treatments. This scoping review aims to map the factors influencing postoperative pain management and recommendations that support optimal, evidence-based pain management after surgery.

A mixed methods scoping review will be conducted in accordance with the Joanna Briggs Institute manual for evidence synthesis and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping review guidelines. PubMed (MEDLINE), Cumulative Index to Nursing & Allied Health Literature and PsycINFO will be searched for the relevant literature from the journals’ inception to September 2025. Two reviewers will independently conduct the screening of titles and abstracts, full-text articles and data extraction. Data will be mapped onto the Theoretical Domains Framework and Capability, Opportunity, Motivation—Behavior model. Where additional data requires coding, thematic analysis will be conducted using NVivo data management software.

The scoping review will analyse publicly available data. Therefore, ethical approval is not required. The findings will serve as a foundation for engaging relevant stakeholders in discussions aimed at implementing systemic changes to support healthcare providers in enhancing postoperative pain management. The results will be disseminated through a peer-reviewed journal publication, local fora and conference presentations to ensure broad visibility and impact.

Inhaled anaesthetics can be used in mechanically ventilated critically ill patients to provide sedation. This approach to sedation potentially improves patient and health system outcomes, but further supportive evidence is needed. The objective of the SAVE-ICU clinical trial is to compare the effectiveness of inhaled versus intravenous sedation in ventilated adults with acute hypoxaemic respiratory failure.

SAVE-ICU is a multicentre, open-label, pragmatic, randomised controlled trial conducted in 15 intensive care units (ICUs) in Canada and the USA. Eligible patients include mechanically ventilated and sedated adults with acute hypoxemic respiratory failure from COVID-19 or non-COVID causes with PaO₂/F_IO₂ ratio 12 hour). A hierarchy of outcomes was identified at the time of trial design, as the trial was launched during the COVID-19 pandemic when study drug shortages, staffing challenges and healthcare system pressures were prevalent and there was a requirement for rapid evidence generation and implementation on this topic. The primary outcome and highest in the hierarchy is hospital mortality (requiring 758 participants). Secondary and lower hierarchical outcomes are ventilator-free days at day 30 (200 patients), quality of life at 3 months (144 participants) and ICU-free days at day 30 (128 participants). Additional secondary outcomes include median daily oxygenation at day 3 (PaO₂/F_IO₂ ratio), need for adjunctive acute respiratory distress syndrome therapies (prone positioning, inhaled nitric oxide, paralysis with a neuromuscular blocking agent and extracorporeal membrane oxygenation) during ICU stay, days alive and free from delirium and coma at day 14, hospital-free days at day 60 and disability score at 3 months and 12 months after enrolment.

The protocol was approved by all hospital ethics committees and by Health Canada. Informed consent will be obtained from substitute decision makers or deferred consent (as permitted by site ethics board). Trial findings will be shared at the end of the study using peer-review publications, conference presentations and social media as part of the trial knowledge translation plan.

NCT04415060.