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

NCT07307495 | Not Yet Recruiting DMC

• 1 other identifier: KY20252506-F-2
• Study Type: interventional
• Target: 428
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Oliceridine Fumarate

Keywords

lumbar spine surgery; gastrointestinal function recovery

Outcome Measures

Primary Outcomes (1)

• Proportion of patients reaching the GI-3 composite endpoint within postoperative 24 hours

  Proportion of patients reaching the GI-3 composite endpoint (tolerating solid food and passing gas/bowel movement) within postoperative 24 hours

  postoperative 24 hours

Secondary Outcomes (6)

• Proportion of patients reaching the GI-3 composite endpoint within postoperative 48 hours

  postoperative 48 hours

• GI-3

  postoperative 48 hours

• IFEED score

  postoperative 24 and 48 hours

• Postoperative SPID

  postoperative 24 and 48 hours

• Opioid consumption

  postoperative 24 and 48 hours

Other Outcomes (1)

• Postoperative nausea and vomiting

  posoperative 48 hours

Study Arms (2)

Oliceridine Group

EXPERIMENTAL

Oliceridine Patient-Controlled Analgesia Pump After Lumbar Spine Surgery

Drug: Oiceridine

Sufentanil Group

ACTIVE COMPARATOR

Sufentanil Patient-Controlled Analgesia Pump After Lumbar Spine Surgery

Drug: Sufentanil

Interventions

Sufentanil DRUG

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.

Sufentanil Group

Oiceridine DRUG

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.

Oliceridine Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

MeSH Terms

Interventions

Sufentanil

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Hailong Dong

CONTACT

13669226699; hldong369@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 29, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-11