RecruitingNot ApplicableNCT06810882

Intravenous Versus Perineural Ondansetron for Laparoscopic Sleeve Gastrectomy

Intravenous Versus Perineural Ondansetron as an Adjuvant in Autonomic Neural Blockade for Laparoscopic Sleeve Gastrectomy: A Two-Center, Randomized, Double-Blind, Non-inferiority Trial

Sponsor

Tanta University

Enrollment

170 participants

Start Date

Feb 16, 2025

Study Type

INTERVENTIONAL

Conditions

Gastrectomy Laparoscopic Ondansetron

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

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..

Exclusion Criteria8

Allergy to experimental drugs.
Known to have long QT, 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, those with surgery-related complications during or after surgery.
Liver or kidney failure
Performance of concomitant procedures in addition to laparoscopic sleeve gastrectomy
Anesthetic complications that may alter the postoperative management protocol.

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Interventions

DRUGPerineural ondansetron

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.

DRUGIntravenous ondansetron

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.