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NOT YET RECRUITING
NCT07307495
NA

Effect of Postoperative Analgesia of Oliceridine Fumarate for Gastrointestinal Function Recovery in Patients Undergoing Lumbar Spine Surgery

Sponsor: Xijing Hospital

View on ClinicalTrials.gov

Summary

Osemitidine fumarate is a novel G protein-biased ligand μ-opioid receptor agonist. Previous studies have confirmed its potent analgesic effects and safety: compared with morphine, it reduces respiratory depression and gastrointestinal dysfunction. This study aims to evaluate the effects of osemitidine on postoperative gastrointestinal function recovery and pain in patients undergoing lumbar spine surgery through a multicenter, double-blind, randomized controlled trial.

Official title: Effect of Postoperative Analgesia of Oliceridine Fumarate for Gastrointestinal Function Recovery in Patients Undergoing Lumbar Spine Surgery:A Prospective, Multicenter, Double-blind,Randomized Controlled Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

428

Start Date

2026-01-01

Completion Date

2027-12-31

Last Updated

2025-12-29

Healthy Volunteers

Yes

Interventions

DRUG

Sufentanil

The postoperative PCA analgesia pump configuration plan is 1.5 μg/kg sufentanil diluted with saline to 100 ml. The specific parameters are a loading dose: 0.1 μg/kg sufentanil diluted with saline to 3 ml, administered 20-30 minutes before the end of surgery. Background infusion rate: 1.5 ml/h, PCA dose: 1 ml, lockout time: 10 minutes.

DRUG

Oiceridine

The postoperative PCA analgesic pump regimen is 0.5 mg/kg of oliceridine diluted with saline to 100 ml. The specific parameters are a loading dose: 0.03 mg/kg of Oxycodone diluted with saline to 3 ml, administered 20-30 minutes before the end of surgery. Background infusion rate: 1.5 ml/h, PCA dose: 1 ml, lockout interval: 10 minutes.