NCT07307495 Effect of Postoperative Analgesia of Oliceridine Fumarate for Gastrointestinal Function Recovery in Patients Undergoing Lumbar Spine Surgery
| NCT ID | NCT07307495 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xijing Hospital |
| Condition | Oliceridine Fumarate |
| Study Type | INTERVENTIONAL |
| Enrollment | 428 participants |
| Start Date | 2026-03-30 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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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.
This trial targets 428 participants in total. It began in 2026-03-30 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07307495 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Oliceridine Fumarate. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07307495 currently recruiting?
Yes, NCT07307495 is actively recruiting participants. Contact the research team at hldong369@hotmail.com for enrollment information.
Where is the NCT07307495 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT07307495 clinical trial?
NCT07307495 is sponsored by Xijing Hospital. The trial plans to enroll 428 participants.