The effects of oliceridine and sufentanil on postoperative nausea and vomiting in abdominal surgery (EOSPONVAS): protocol for a multicentre, two-arm, randomised controlled trial

BMJ Open. 2025 Sep 30;15(9):e106066. doi: 10.1136/bmjopen-2025-106066.

ABSTRACT

INTRODUCTION: Oliceridine is a novel μ-opioid receptor selective agonist that provides analgesia while reducing μ-receptor-mediated adverse effects such as postoperative nausea and vomiting (PONV). Evidence in abdominal surgery remains limited. This study aims to determine whether oliceridine reduces PONV and improves recovery in abdominal surgery.

METHODS AND ANALYSIS: This is a prospective, multicentre, two-arm, randomised trial. Participants aged 18-65 years, with American Society of Anesthesiologists physical status I-III and a body mass index of 18.5-23.9 kg/m², undergoing elective major abdominal surgery, will be eligible for inclusion. Gynaecological surgeries are excluded. All patients must require postoperative intravenous patient-controlled analgesia (PCIA) and give written consent. 494 participants will be randomised to oliceridine group or sufentanil group. The primary outcome is the incidence of PONV within 48 hours postsurgery. Secondary outcomes include vomiting frequency, nausea severity score, use of rescue antiemetics, resting numerical rating scale (NRS) pain score, Quality of Recovery-15 (QoR-15) score, time to first postoperative flatus, intensive care unit (ICU) length of stay (LOS), hospital LOS and PCIA metrics (effective attempts and total volume used). Safety outcomes include other opioid-related adverse effects (ORAEs) (eg, respiratory depression, pruritus, dizziness, headache), complications related to PONV (eg, electrolyte disturbances, wound dehiscence) and other perioperative complications.

ETHICS AND DISSEMINATION: This protocol was approved (Version V3.0, 2025-01-14) by the Ethics Committee of Changhai Hospital (CHEC-2025-069), the Shanghai Public Health Clinical Centre (2025-S024-01) and the Wusong Central Hospital of Baoshan District, Shanghai (2025-17-01). It complies with the Declaration of Helsinki. Results will be shared via conferences and peer-reviewed journals.

TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry (ID: ChiCTR2400089262).

PMID:41027692 | DOI:10.1136/bmjopen-2025-106066