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NOT YET RECRUITING
NCT07105839
PHASE4

Opioid-Free Versus Opioid-Based Anesthesia in Bariatric

Sponsor: Siirt Training and Research Hospital

View on ClinicalTrials.gov

Summary

This study is designed as a prospective, randomized, controlled clinical trial. It will be conducted in the operating rooms of the University of Health Sciences, Diyarbakır Gazi Yaşargil Training and Research Hospital. Patients aged 18 to 65 years who are scheduled for elective bariatric surgery and meet the inclusion criteria (ASA physical status I-III) will be enrolled in the study. Eligible patients will be informed both verbally and in writing during their preoperative anesthetic evaluation, and written informed consent will be obtained at least 24 hours prior to surgery. Patients will be randomly assigned to one of two groups using computer-generated randomization: Group O (Opioid group) Group NO (Opioid-free group) All patients will receive 40 mg IV pantoprazole and 4 mg IV ondansetron 30 minutes before surgery as preoperative medication. Standard ASA monitoring will be applied, and fasting guidelines will be followed. Depth of anesthesia will be monitored in all patients using BIS, and maintained within a target range of BIS 40-60 to ensure adequate depth with no response to surgical stimuli.

Official title: A Prospective, Randomized Controlled Trial Comparing Opioid-Free and Opioid-Based Anesthesia in Morbidly Obese Patients Undergoing Bariatric Surgery

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-08-20

Completion Date

2026-03-01

Last Updated

2025-08-06

Healthy Volunteers

No

Interventions

DRUG

Intraoperative rescue analgesia

If signs of inadequate analgesia occur (e.g., \>20% increase in heart rate or blood pressure), IV remifentanil infusion rate will be titrated upward within the safety margin.

DRUG

Intraoperative rescue analgesia:

If signs of inadequate analgesia occur (e.g., \>20% increase in heart rate or blood pressure), IV dexmedetomidine infusion rate will be titrated upward (up to maximum safe dose).