INDEX study: intravenous dexamethasone palmitate for prophylaxis of postoperative nausea and vomiting: a study protocol for a randomised controlled study.

INTRODUCTION

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.

METHODS AND ANALYSIS: 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.

ETHICS AND DISSEMINATION: 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.

TRIAL REGISTRATION NUMBER: NCT06981754.