Opioid-Free Versus Opioid-Based Anesthesia in Bariatric

NCT07105839 | Not Yet Recruiting Phase 4

• 1 other identifier: OBES-OFAN-2025-01
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Bariatric Surgery

Keywords

Opioid-Free Anesthesia; Pain Management; Multimodal Analgesia; Quality of Recovery (QoR-15); TAP Block

Outcome Measures

Primary Outcomes (2)

• Postoperative VAS pain scores

  post-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

Secondary Outcomes (2)

• Rescue analgesic requirement

  Within 48 hours post-op

• Postoperative nausea and vomiting (PONV) incidence questionnaire

  48 hours

Study Arms (2)

Group O (Opioid Group)

ACTIVE COMPARATOR

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

Drug: Intraoperative rescue analgesia

Group NO (Opioid-Free Group)

ACTIVE COMPARATOR

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

Drug: Intraoperative rescue analgesia:

Interventions

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).

Group NO (Opioid-Free Group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Refusal to participate
• Severe cardiac/pulmonary/psychiatric illness
• Allergy to study drugs
• Conversion to emergency surgery
• Withdrawal at any point by patient or investigator

Sponsors & Collaborators

• Siirt Training and Research Hospital: lead

MeSH Terms

Conditions

Obesity; Agnosia

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases

Central Study Contacts

ali K oğuz, specialist Dr in Anestesiology

CONTACT

+905324683045; alikendal.oguz@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Doctor In Anestesiology And Reanimation

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: August 20, 2025
• Primary Completion: January 20, 2026
• Study Completion: March 1, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-07