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

Air Force Military Medical University of People's Liberation Army

Status: Not yet enrolling

Conditions: Oliceridine Fumarate

Treatments: Drug: Sufentanil; Drug: Oiceridine

Study type: Interventional

Funder types: Other

Identifiers

NCT07307495

KY20252506-F-2

Details and patient eligibility

About

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.

Enrollment: 428 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 18 and 75 years old;
• Patients undergoing lumbar surgery under general anesthesia (within 3 segments) and expected to receive postoperative patient-controlled analgesia;
• ASA classification I-III;
• BMI between 18 and 30 kg/m²;
• Informed consent obtained from the patient.

Exclusion criteria

• Use of any painkillers within 3 days before surgery; or long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs), defined as: within 3 months before surgery, use of NSAIDs daily for more than 2 consecutive weeks;
• Presence of intestinal obstruction or suspicious symptoms: nausea and vomiting, abdominal bloating and pain, cessation of gas or bowel movements within the past two weeks, imaging suggesting intestinal dilation, or large amounts of air-fluid levels;
• Patients with severe liver dysfunction (based on Child-Pugh classification, grade C);
• History of or planned gastrointestinal surgery;
• Patients allergic to the study drug;
• Pregnant or breastfeeding patients;
• QTcF abnormalities, males >450 ms, females >470 ms;
• Participation in other drug trials within the past 30 days;
• Long-term use of opioids (defined as: within 12 months before surgery, use for more than 1 month, more than 3 days per week, with daily doses exceeding 15 mg morphine equivalent);
• Pre-existing neurological or psychiatric disorders: such as epilepsy, depression, schizophrenia, etc.;
• Patients deemed unsuitable for this study by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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428 participants in 2 patient groups

Oliceridine Group

Experimental group

Description:

Oliceridine Patient-Controlled Analgesia Pump After Lumbar Spine Surgery

Treatment:

Drug: Oiceridine

Sufentanil Group

Active Comparator group

Description:

Sufentanil Patient-Controlled Analgesia Pump After Lumbar Spine Surgery

Treatment:

Drug: Sufentanil