IntroductionPostoperative delirium (POD) is a common and distressing complication after thoracic surgery. S-ketamine has neuroprotective properties as a dissociative anaesthetic. Emerging literature has indicated that S-ketamine can reduce cognitive impairment in patients with depression. However, the role of S-ketamine in preventing POD remains unknown. Therefore, this study aims to evaluate the effect of intraoperative prophylactic S-ketamine compared with that of dexmedetomidine on the incidence of POD in elderly patients undergoing non-cardiac thoracic surgery.Methods and analysisThis will be a randomised, double-blinded, placebo-controlled, positive-controlled, non-inferiority trial that enrolled patients aged 60–90 years undergoing thoracic surgery. The patients will be randomly allocated in a ratio of 1:1:1 to S-ketamine, dexmedetomidine or normal saline placebo groups using computer-generated randomisation with a block size of six. The primary outcome will be the incidence of POD within 4 days after surgery and this will be assessed using a 3-Minute Diagnostic Confusion Assessment Method two times per day. The severity and duration of POD, the incidence of emergence delirium, postoperative pain, quality of sleep, cognitive function, and the plasma concentrations of acetylcholine, brain-derived neurotrophic factor, tumour necrosis factor-α and incidence of adverse events will be evaluated as secondary outcomes.Ethics and disseminationEthical approval has been obtained from the Institutional Review Board of the Cancer Hospital and the Institute of Guangzhou Medical University (ZN202119). At the end of the trial, we commit to making a public disclosure available, regardless of the outcome. The public disclosure will include a publication in an appropriate journal and an oral presentation at academic meetings.Trial registration numberChiCTR2100052750 (NCT05242692).
IntroductionPostoperative pulmonary complications (PPCs) occur after up to 60% of non-cardiac thoracic surgery (NCTS), especially for multimorbid elderly patients. Nevertheless, current risk prediction models for PPCs have major limitations regarding derivation and validation, and do not account for the specific risks of NCTS patients. Well-founded and externally validated models specific to elderly NCTS patients are warranted to inform consent and treatment decisions.Methods and analysisWe will develop, internally and externally validate a multivariable risk model to predict 30-day PPCs in elderly NCTS patients. Our cohort will be generated in three study sites in southern China with a target population of approximately 1400 between October 2021 and December 2023. Candidate predictors have been selected based on published data, clinical expertise and epidemiological knowledge. Our model will be derived using the combination of multivariable logistic regression and bootstrapping technique to lessen predictors. The final model will be internally validated using bootstrapping validation technique and externally validated using data from different study sites. A parsimonious risk score will then be developed on the basis of beta estimates derived from the logistic model. Model performance will be evaluated using area under the receiver operating characteristic curve, max-rescaled Brier score and calibration slope. In exploratory analysis, we will also assess the net benefit of Probability of PPCs Associated with THoracic surgery in elderly patients score in the complete cohort using decision curve analysis.Ethics and disseminationEthical approval has been obtained from the Institutional Review Board of the Affiliated Cancer Hospital and Institute of Guangzhou Medical University, the Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine and the University of Hongkong—Shenzhen Hospital, respectively. The final risk prediction model will be published in an appropriate journal and further disseminated as an online calculator or nomogram for clinical application. Approved and anonymised data will be shared.Trial registration numberChiCTR2100051170.
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