Effects of tegileridine versus sufentanil on postoperative nausea and vomiting in female patients undergoing laparoscopic cholecystectomy with a multimodal antiemetic approach based in Chengdu, China: protocol for a dual-centre randomised controlled trial.

INTRODUCTION

Postoperative nausea and vomiting (PONV) remains one of the most common complications after laparoscopic cholecystectomy, especially in female patients faced with high baseline risk. Although multimodal antiemetic strategies are routinely used in perioperative care, opioid exposure remains an important contributor to PONV. Tegileridine, a novel G protein-biased μ-opioid receptor agonist, may provide effective analgesia with fewer gastrointestinal adverse effects than conventional opioids such as sufentanil. However, evidence on its role in preventing PONV in female patients undergoing laparoscopic cholecystectomy remains limited.

METHODS AND ANALYSIS: This dual-centre, randomised controlled trial will enrol 148 female patients undergoing elective laparoscopic cholecystectomy at two tertiary hospitals in Chengdu, China. Participants will be randomly assigned individually (1:1 ratio) to receive either tegileridine-based or sufentanil-based perioperative analgesia within a standardised multimodal antiemetic framework. Randomisation will be centrally performed using a web-based system with allocation concealment. Participants, postoperative outcome assessors and data analysts will remain blinded to treatment allocation. The primary outcome will be the overall incidence of PONV within 24 hours after surgery. Secondary outcomes will include the incidence and severity of nausea and vomiting at predefined postoperative time points, pain scores, use of rescue analgesic and antiemetic medication, quality of recovery, opioid-related adverse events and recovery-related time-dependent outcomes.

ETHICS AND DISSEMINATION: This study has been approved by the ethics committees of West China Hospital, Sichuan University and West China Tianfu Hospital, Sichuan University (ethical review no. 1775.2025). Written informed consent will be obtained from all participants before enrolment. The findings will be disseminated through peer-reviewed publications and academic conferences.

TRIAL REGISTRATION NUMBER: ChiCTR2500111528.