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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
428
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.
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.
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
Time frame: postoperative 24 hours
Proportion of patients reaching the GI-3 composite endpoint within postoperative 48 hours
Proportion of patients reaching the GI-3 composite endpoint (tolerating solid food and passing gas/bowel movement) within postoperative 48 hours
Time frame: postoperative 48 hours
GI-3
GI-3: Reach the later of the following two milestones: ① Time of solid food tolerance: No vomiting occurs within 4 hours after eating food that requires chewing ; ② Time of first flatus or first bowel movement (whichever comes first).
Time frame: postoperative 48 hours
IFEED score
IFEED scores at postoperative 24 and 48 hours The I-FEED score is a novel outcome measure for POI, developed by expert consensus. It contains five elements (intake, response to nausea treatment, emesis, exam, and duration, each scored with 0, 1, or 3 points) and classifies patients into normal, postoperative gastrointestinal intolerance (POGI), and postoperative gastrointestinal dysfunction (POGD)(normal 0-2, POGI 3-5, POGD 6+ points)
Time frame: postoperative 24 and 48 hours
Postoperative SPID
Summed Pain Intensity Difference at postoperative 24 and 48 hours
Time frame: postoperative 24 and 48 hours
Opioid consumption
Opioid consumption at postoperative 24 and 48 hours
Time frame: postoperative 24 and 48 hours
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remedial analgesia
Times of remedial analgesia at postoperative 48 hours
Time frame: postoperative 48 hours