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NCT07105839Not yet recruitingPhase 4

Opioid-Free Versus Opioid-Based Anesthesia in Bariatric

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

Source: ClinicalTrials.gov · Last updated 6 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
50 (estimated)
First submitted
30 Jul 2025
Start date
20 Aug 2025
Primary completion date
20 Jan 2026
Lead sponsor
Siirt Training and Research Hospital
Diseases
Obesity
NCT number
NCT07105839

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 50
  • From 20 Aug 2025 to the primary completion date, 20 Jan 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Conversion to emergency surgery

Other illness

  • Severe cardiac/pulmonary/psychiatric illness
  • Allergy to study drugs

Other

  • Refusal to participate
  • Withdrawal at any point by patient or investigator
  • \-

Who the study is looking for

  • Age 18-65 years
  • BMI \>35
  • ASA class III-IV
  • Elective bariatric surgery (e.g., sleeve gastrectomy)
  • Written informed consent

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.