Intravenous Versus Perineural Ondansetron as an Adjuvant in Autonomic Neural Blockade for Laparoscopic Sleeve Gastrectomy: A Two-Center, Randomized, Double-Blind, Non-inferiority Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This prospective randomized non-inferiority study will be conducted to compare the analgesic anti-emetic effects of intravenous ondansetron versus perineural ondansetron in patients undergoing laparoscopic sleeve gastrectomy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Patients of either sex
• American Society Anesthesiologists physical (ASA) status II-III
• age between 18-65 years old
• Body mass index (BMI) \>35 kg/m2 with comorbidity or \> 40 kg/m2 -- undergoing laparoscopic sleeve gastrectomy with intraoperative surgeon performed laparoscopic paragastric autonomic neural blockade..
Locations
Other Locations
Egypt
Tanta University Hospitals
RECRUITING
Tanta
Contact Information
Primary
Osama M Rehab, MD
osamarehab@med.tanta.edu.eg
01095210806
Time Frame
Start Date: 2025-02-16
Estimated Completion Date: 2026-03-17
Participants
Target number of participants: 170
Treatments
Experimental: Perineural ondansetron group
Para-gastric autonomic neural blockade will be performed (after separation of the stomach and performing the methylene blue leak test) using 20 ml solution containing 18 ml bupivacaine 0.5% plus 2 ml (4 mg) ondansetron. At the same time, 15 ml saline will be injected slowly IV over 15 minutes.
Active_comparator: Intravenous ondansetron group
Para-gastric autonomic neural blockade will be performed (after separation of the stomach and performing the methylene blue leak test) using 20 ml solution containing 18 ml bupivacaine 0.5% plus 2 ml saline. At the same time, 4 mg (2 ml) ondansetron mixed with 13 ml saline (total 15 ml) will be slowly injected IV over 15 minutes.
Related Therapeutic Areas
Sponsors
Leads: Tanta University