Opioid-Free Versus Opioid-Based Anesthesia in Bariatric

NCT ID: NCT07105839

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-20
• Study Completion Date: 2026-03-01

Brief 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.

Detailed Description

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.

Conditions

Obesity; Bariatric Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group O (Opioid Group)

Induction with: 2 mg/kg IV propofol, 2 μg/kg fentanyl, 0.6 mg/kg rocuronium (ideal body weight)

Maintenance:0.1-0.3 μg/kg/min IV remifentanil infusion and 1 MAC sevoflurane

Bilateral TAP block: 40 mL of 0.25% bupivacaine under ultrasound guidance

Group Type: ACTIVE_COMPARATOR

Intraoperative rescue analgesia

Intervention Type: 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.

Group NO (Opioid-Free Group)

Induction with: 2 mg/kg IV propofol, 0.5 mg/kg ketamine, 0.6 mg/kg rocuronium

Maintenance: 0.2-1.4 μg/kg/h IV dexmedetomidine and 1 MAC sevoflurane

Bilateral TAP block: 40 mL of 0.25% bupivacaine under ultrasound guidance

Group Type: ACTIVE_COMPARATOR

Intraoperative rescue analgesia:

Intervention Type: 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).

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.

Intervention Type: DRUG

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).

Intervention Type: DRUG

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Siirt Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

ali kendal oğuz

Specialist Doctor In Anestesiology And Reanimation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

ali K oğuz, specialist Dr in Anestesiology

Role: CONTACT

alikendal.oguz@sbu.edu.tr

+905324683045

Other Identifiers

OBES-OFAN-2025-01

Identifier Type: -

Identifier Source: org_study_id