NCT07924306 Effects of Biased Opioid Agonists on Gastrointestinal Recovery After Gynecologic Laparoscopic Surgery

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 212 participants in total. It began in 2026-06-01 with a primary completion date of 2026-12-20.

Brief Summary

This randomized controlled clinical trial aims to evaluate the effects of different opioid analgesics on gastrointestinal recovery after gynecologic laparoscopic surgery. Opioid medications are commonly used to manage pain after surgery, but they may cause nausea, vomiting, constipation, and delayed recovery of bowel function. Biased μ-opioid receptor agonists, such as tegileridine and oliceridine, may provide effective pain relief with fewer gastrointestinal side effects than conventional opioids. The main question is whether biased opioid receptor agonists can shorten the time to postoperative gastrointestinal recovery compared with sufentanil, a conventional opioid analgesic. The study plans to enroll 212 adults undergoing elective gynecologic laparoscopic surgery. Participants will be randomly assigned to one of four groups: * Lower-dose tegileridine * Higher-dose tegileridine * Oliceridine * Sufentanil After surgery, participants will receive the assigned medication through a patient-controlled intravenous analgesia (PCIA) pump. The primary outcome is time to gastrointestinal recovery (GI-2), defined as the time from the end of surgery until both the first bowel movement (defecation) and tolerance of solid food have occurred. The later of these two events determines the GI-2 recovery time. Researchers will also assess the time to first passage of flatus, postoperative nausea and vomiting, gastrointestinal function scores, pain intensity, gastrointestinal ultrasound findings, analgesic requirements, and medication-related adverse events. The findings may help determine whether biased opioid receptor agonists offer advantages over conventional opioid analgesics in supporting gastrointestinal recovery while maintaining adequate postoperative pain control.

Eligibility Criteria

Inclusion Criteria: * Female patients aged 18 to 75 years scheduled for elective gynecologic laparoscopic surgery. * American Society of Anesthesiologists (ASA) physical status I-III. * Body mass index (BMI) between 18 and 30 kg/m². * Normal preoperative liver and kidney function, with cardiopulmonary function adequate to tolerate surgery. * Voluntary provision of written informed consent. Exclusion Criteria: * Inability to provide informed consent before surgery or difficulty communicating. * Known allergy to any of the study medications. * Severe hepatic impairment (Child-Pugh class C), severe renal impairment (creatinine clearance below 30 mL/min), or ongoing long-term dialysis. * Severe cardiovascular or cerebrovascular disease, including myocardial infarction, cardiac arrest, decompensated heart failure, significant arrhythmias (such as second-degree or higher atrioventricular block without a pacemaker), congenital heart disease, severe valvular disease, extensive cerebral hemorrhage, or cerebral infarction; or significant respiratory disease, including a history of asthma, acute exacerbation of chronic obstructive pulmonary disease, or previous pulmonary resection. * History of long-term opioid use before surgery or chronic pain. * Pregnancy or breastfeeding. * Other severe medical conditions or psychiatric disorders that make participation in the study unsuitable.

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