Not Yet RecruitingPhase 4Other

Opioid-Free Versus Opioid-Based Anesthesia in Bariatric

Sponsored by Siirt Training and Research Hospital

NCT ID
NCT07105839
Target Enrollment
50 participants
Start Date
2025-08-20
Est. Completion
2026-03-01

About This Study

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.

Conditions Studied

ObesityBariatric Surgery

Interventions

  • Intraoperative rescue analgesia
  • Intraoperative rescue analgesia:

Eligibility

Age:18 Years - 65 Years
Healthy Volunteers:No
View full eligibility 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

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Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

ali K oğuz, specialist Dr in Anestesiology
CONTACT
+905324683045alikendal.oguz@sbu.edu.tr
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source

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