Clinical trial

Opioid-Free Versus Opioid-Based Anesthesia in Bariatric

Opening soon · Phase 4 · 0 countries · Registry ID NCT07105839

Opening soonPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Bariatric Surgery

Full registry criteria

Inclusion Criteria: Age 18-65 years BMI \>35 ASA class III-IV Elective bariatric surgery (e.g., sleeve gastrectomy) Written informed consent Exclusion Criteria: Refusal to participate Severe cardiac/pulmonary/psychiatric illness Allergy to study drugs Conversion to emergency surgery Withdrawal at any point by patient or investigator \-

Treatments and study arms

Intraoperative rescue analgesia

Drug

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:

Drug

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).

Primary outcomes

Postoperative VAS pain scorespost-op 1.hour (H), 2.H, 3.H, 6.H, 12.H, 18.H, 24.H, 36.H and 48.H

QoR-15 score (Quality of Recovery)24 Hours and 48 Hours

Study locations

0 locations were listed when this page was built. The first 40 are shown.

No public site location was included in this record. Check the original registry for updates.