A Prospective, Randomized Controlled Trial Comparing Opioid-Free and Opioid-Based Anesthesia in Morbidly Obese Patients Undergoing Bariatric Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Postoperative VAS pain scores
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •ASA class III-IV
- •Elective bariatric surgery (e.g., sleeve gastrectomy)
- •Written informed consent
排除标准
- •Refusal to participate
- •Severe cardiac/pulmonary/psychiatric illness
- •Allergy to study drugs
- •Conversion to emergency surgery
- •Withdrawal at any point by patient or investigator
研究组 & 干预措施
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
干预措施: Intraoperative rescue analgesia (Drug)
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
干预措施: Intraoperative rescue analgesia (Drug)
结局指标
主要结局
Postoperative VAS pain scores
时间窗: 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)
时间窗: 24 Hours and 48 Hours
次要结局
- Rescue analgesic requirement(Within 48 hours post-op)
- Postoperative nausea and vomiting (PONV) incidence questionnaire(48 hours)
研究者
ali kendal oğuz
Specialist Doctor In Anestesiology And Reanimation
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital