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NCT Number: NCT07105839

Opioid-Free Versus Opioid-Based Anesthesia in Bariatric

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.

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Key information

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.

Anesthesia Protocol:

Group O (Opioid Group):

General anesthesia will be induced with 2 mg/kg propofol, 2 µg/kg fentanyl, and 0.6 mg/kg rocuronium based on ideal body weight (IBW). Maintenance will be achieved using remifentanil (Ultiva®) infusion at 0.1-0.3 µg/kg/min and 1 MAC sevoflurane. Following induction, all patients will receive a bilateral transversus abdominis plane (TAP) block under ultrasound guidance using 40 mL of 0.25% bupivacaine.

Group NO (Opioid-Free Group):

General anesthesia will be induced with 2 mg/kg propofol, 0.5 mg/kg ketamine, and 0.6 mg/kg rocuronium (IBW). Anesthesia will be maintained with dexmedetomidine infusion at 0.2-1.4 µg/kg/h and 1 MAC sevoflurane. Following induction, a bilateral TAP block will also be performed using 40 mL of 0.25% bupivacaine under ultrasound guidance.

Postoperative Analgesia Protocol:

During skin closure, all patients will receive 1 g IV paracetamol and 50 mg IV ketoprofen. At the end of surgery, neuromuscular blockade will be reversed using sugammadex, and patients will be safely extubated.

In the postoperative period, patients will be followed in the surgical ward for 48 hours with a standardized analgesic protocol:

1 g IV paracetamol every 6 hours

4 mg IV ondansetron every 8 hours

50 mg IV ketoprofen every 12 hours

Pain will be assessed using the Visual Analog Scale (VAS). If VAS ≥ 4, 100 mg IV tramadol will be administered as rescue analgesia, and all interventions will be documented in the patient records.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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

  1. Postoperative VAS pain scores

    Time frame: post-op 1.hour (H), 2.H, 3.H, 6.H, 12.H, 18.H, 24.H, 36.H and 48.H

  2. QoR-15 score (Quality of Recovery)

    Time frame: 24 Hours and 48 Hours

Secondary outcomes

  1. Rescue analgesic requirement

    Time frame: Within 48 hours post-op

    IV tramadol

  2. Postoperative nausea and vomiting (PONV) incidence questionnaire

    Time frame: 48 hours

Study contacts

Contact information is provided by the study sponsor or research team.

ali K oğuz, specialist Dr in Anestesiology

CONTACT

[email protected]

+905324683045

Sponsors and collaborators

Lead sponsor

Siirt Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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