Opioid-Free Versus Opioid-Based Anesthesia in Bariatric
- Conditions
- ObesityBariatric Surgery
- Interventions
- Drug: Intraoperative rescue analgesia
- Registration Number
- NCT07105839
- Lead Sponsor
- Siirt Training and Research Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
Age 18-65 years
BMI >35
ASA class III-IV
Elective bariatric surgery (e.g., sleeve gastrectomy)
Written informed consent
Refusal to participate
Severe cardiac/pulmonary/psychiatric illness
Allergy to study drugs
Conversion to emergency surgery
Withdrawal at any point by patient or investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group O (Opioid Group) Intraoperative rescue analgesia 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 NO (Opioid-Free Group) Intraoperative rescue analgesia 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Rescue analgesic requirement Within 48 hours post-op IV tramadol
Postoperative nausea and vomiting (PONV) incidence questionnaire 48 hours