Effects of ondansetron applied before the induction of anaesthesia on postoperative nausea and vomiting in high-risk patients: protocol for a randomised controlled trial.

Introduction: Postoperative nausea and vomiting (PONV) is a common complication following various surgical procedures, significantly contributing to patient discomfort and increasing healthcare costs. Despite the widespread use of multiple drug combinations, PONV remains a persistent challenge, particularly in high-risk populations. Existing evidence suggests a potential interaction between 5-HT3 receptors and μ-opioid receptors, indicating that they may function as co-receptors with a competitive relationship. Based on this hypothesis, we designed experiments to investigate this correlation.

Methods And Analysis: This randomised, parallel, positive-controlled, double-blind (both intervener and participant) trial will take place at the Affiliated Hospital of Shandong University of Traditional Chinese Medicine. Based on relevant literature and our pre-test, the incidence of PONV in the intervention group is estimated to be approximately 30%. With an expected 10% loss-to-follow-up rate and a desired statistical power of 0.9 (1-β), the required sample size for each group is 65 participants, totalling 130 subjects to be enrolled from 30 March 2025 to 30 April 2025. Eligible patients will be randomly allocated to either the intervention or control group. Ondansetron will be administered 15 min before anaesthesia induction in the intervention group (n=65) and at the end of surgery in the control group (n=65). The primary outcome is the incidence of PONV within the 0-24-hour postoperative period. The sample size will be calculated using PASS 15, statistical analysis will be conducted using SPSS 25 and missing data will be addressed using the Last Observation Carried Forward method. Two-tailed tests will be employed, with significance set at α=0.05. Results will be considered significant if p<0.05.

Ethics And Dissemination: Ethical approval for the study was obtained from the Affiliated Hospital of Shandong University of Traditional Chinese Medicine. All raw data from the trial will be made available on Dryad.

Trial Registration Number: The trial is registered with China's Clinical Trial Registry (www.chictr.org.cn) under the registration number ChiCTR2400086696.