Skip to content

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07105839
Enrollment
50
Registered
2025-08-06
Start date
2025-08-20
Completion date
2026-03-01
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Obesity

Keywords

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

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.

Interventions

DRUGIntraoperative 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.

DRUGIntraoperative 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).

Sponsors

Siirt Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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 \-

Design outcomes

Primary

MeasureTime frame
Postoperative VAS pain scorespost-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

MeasureTime frameDescription
Rescue analgesic requirementWithin 48 hours post-opIV tramadol
Postoperative nausea and vomiting (PONV) incidence questionnaire48 hours

Contacts

Primary Contactali K oğuz, specialist Dr in Anestesiology
alikendal.oguz@sbu.edu.tr+905324683045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026