Effect of Postoperative Analgesia of Oliceridine Fumarate for Gastrointestinal Function Recovery in Patients Undergoing Lumbar Spine Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sufentanil, Oiceridine.
- Who it may be relevant to
- Registry conditions: Oliceridine Fumarate. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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.
Primary outcome measures
- Proportion of patients reaching the GI-3 composite endpoint within postoperative 24 hours [Time frame: postoperative 24 hours]
Secondary outcome measures (6)
- Proportion of patients reaching the GI-3 composite endpoint within postoperative 48 hours [Time frame: postoperative 48 hours]
- GI-3 [Time frame: postoperative 48 hours]
- IFEED score [Time frame: postoperative 24 and 48 hours]
- Postoperative SPID [Time frame: postoperative 24 and 48 hours]
- Opioid consumption [Time frame: postoperative 24 and 48 hours]
- remedial analgesia [Time frame: postoperative 48 hours]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- the First Affiliated Hospital of Air Force Military Medical University — Xi'an
Identifiers
NCT: NCT07307495 · KY20252506-F-2