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Opioid-Free Versus Opioid-Based Anesthesia in Bariatric
Sponsor: Siirt Training and Research Hospital
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
Conditions
Interventions
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.
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).