Actively Recruiting
Intravenous Versus Perineural Ondansetron as an Adjuvant in Autonomic Neural Blockade for Laparoscopic Sleeve Gastrectomy: A Two-Center, Randomized, Double-Blind, Non-inferiority Trial
Led by Tanta University · Updated on 2026-05-15
482
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of ondansetron, a drug commonly used to manage nausea and vomiting after surgery, in patients undergoing laparoscopic sleeve gastrectomy, a weight loss surgery for obesity. This study compares the anti-nausea and pain-relief effects of ondansetron given through an intravenous (IV) route versus delivered perineurally as part of a nerve block during surgery. The goal is to see if the perineural method is not worse than IV treatment for preventing nausea and vomiting and if it can better reduce postoperative pain. Participants will receive a para-gastric autonomic neural blockade during surgery, where a local anesthetic mixture is injected near nerves around the stomach. One group will get ondansetron mixed with the anesthetic injected perineurally, along with a saline IV injection. The other group will receive ondansetron IV with saline mixed in the nerve block. The nerve block solution contains bupivacaine and either ondansetron or saline. The IV injections are given slowly over 15 minutes. This randomized, double-blind trial will test these two methods to compare effects. During the study, researchers will measure vomiting in the first 8 hours after surgery and pain levels at 1 hour post-surgery using a pain rating scale. Further assessments of nausea, vomiting, pain, use of rescue medications, opioid doses, and patient satisfaction will be done up to 24 hours after surgery. Participants will be monitored closely for safety and changes in symptoms. The total participation duration covers the immediate postoperative period, with important outcomes focused on the first day after surgery.
CONDITIONS
Brief Title
Intravenous Versus Perineural Ondansetron for Laparoscopic Sleeve Gastrectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of either sex
- American Society Anesthesiologists physical (ASA) status II-III
- Age between 18 and 65 years
- Body mass index (BMI) greater than 35 kg/m2 with comorbidity or greater than 40 kg/m2
- Undergoing laparoscopic sleeve gastrectomy with intraoperative surgeon performed laparoscopic paragastric autonomic neural blockade
You will not qualify if you...
- Allergy to experimental drugs
- Known to have long QT syndrome or previous history of postoperative nausea and vomiting
- Abuse of alcohol, analgesia, or sedative antidepressant drugs
- Chronic pain disorders
- History of previous upper gastrointestinal system surgery or surgery-related complications
- Liver or kidney failure
- Performance of concomitant procedures in addition to laparoscopic sleeve gastrectomy
- Anesthetic complications that may alter the postoperative management protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Surgery day and up to 24 hours after surgery
Participants undergo laparoscopic sleeve gastrectomy with paragastric autonomic neural blockade and receive ondansetron either perineurally or intravenously during surgery to help manage postoperative nausea, vomiting, and pain.
1 surgical visit and monitoring during the first 24 hours post-surgery
Duration - 24 hours after surgery
Participants are monitored for postoperative nausea, vomiting, and pain through 24 hours after surgery, including assessments of pain scores and use of rescue medications.
Follow-up assessments within the first day after surgery
Trial Site Locations
Total: 1 location
1
Tanta University Hospitals
Tanta, Gharbia Governorate, Egypt, 31527
Actively Recruiting
Research Team
O
Osama M Rehab, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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