Opioid-free Anesthesia vs Opioid-based Anesthesia / A Heavyweight Showdown - Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity Measured by the Numerical Rating Scale for Pain (NRS)
研究概览
简要总结
This prospective randomized controlled trial aims to compare the clinical effectiveness and safety of opioid-free anesthesia (OFA) versus traditional opioid-based anesthesia (OBA) in adult patients undergoing laparoscopic bariatric surgery. The study evaluates postoperative pain, need for rescue analgesia, incidence of postoperative nausea and vomiting (PONV), intraoperative nociception monitoring (NOL index), and patient satisfaction. A total of 60 patients were randomized into two parallel groups receiving either OFA or OBA according to standardized anesthetic protocols.
详细描述
Bariatric surgery is the most effective treatment for severe and morbid obesity, but perioperative pain management and PONV remain significant challenges. Traditional opioid-based anesthesia is associated with adverse effects such as respiratory depression, postoperative hyperalgesia, ileus, and delayed recovery.
Opioid-free anesthesia is an emerging strategy based on the use of multimodal, non-opioid agents-including dexmedetomidine, lidocaine, and ketamine-aimed at providing adequate analgesia while reducing opioid-related complications.
This randomized controlled trial evaluates whether OFA improves postoperative pain control, reduces the requirement for rescue analgesia, and promotes better perioperative outcomes compared to OBA in laparoscopic bariatric surgery. Outcomes include NRS pain scores at multiple time points, NOL monitoring during surgery, PONV occurrence, and patient satisfaction at discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No blinding was implemented. Both participants and care providers were aware of group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Body mass index (BMI ≥ 35 kg/m² with associated comorbidities) or BMI ≥ 40 kg/m²;
- •Scheduled for elective laparoscopic bariatric surgery;
- •Ability to provide informed consent.
排除标准
- •Pregnancy;
- •History of substance abuse;
- •Severe psychiatric disease;
- •Contraindications to any of the drugs used in either anesthetic protocol (dexmedetomidine, ketamine, lidocaine, remifentanil, etc.);
- •Inability to comply with study procedures;
- •Refusal or inability to provide informed consent.
研究组 & 干预措施
Opioid-Based Anesthesia (OBA)
Standard opioid-based anesthesia using remifentanil infusion plus propofol induction, desflurane maintenance, and conventional multimodal analgesia, with opioids permitted for rescue.
干预措施: Opioid-Based Anesthesia (Remifentanil-Based Protocol) (Drug)
Opioid-Free Anesthesia (OFA)
Opioid-free anesthesia using dexmedetomidine, ketamine, and lidocaine infusion, combined with propofol induction, desflurane maintenance, and opioid-free multimodal analgesia, continued into early recovery.
干预措施: Opioid-Free Anesthesia (Dexmedetomidine-Ketamine-Lidocaine Protocol) (Drug)
结局指标
主要结局
Postoperative Pain Intensity Measured by the Numerical Rating Scale for Pain (NRS)
时间窗: Time Frame: - Within 30 minutes of arrival at the Post-Anesthesia Care Unit (PACU); - At PACU discharge (assessed up to 2 hours after PACU admission); - Within the first 24 postoperative hours; - 48 hours postoperatively (at hospital discharge).
Postoperative pain will be assessed using the Numerical Rating Scale for Pain (NRS), a validated 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate a worse outcome, reflecting greater pain intensity. Pain intensity will be compared between the opioid-free anesthesia group and the opioid-based anesthesia group at predefined postoperative time points.
次要结局
- Intraoperative Nociception (NOL Index)(Multiple standardized time points during surgery (15 to 180 minutes))
- Need for Rescue Analgesia(- During PACU stay (assessed up to 2 hours after PACU admission).)
- Opioid Consumption(- During PACU stay (assessed up to 2 hours after PACU admission).)
- Incidence of Postoperative Nausea and Vomiting (PONV)(At 6 hours and 24 hours after surgery)
- Need for PONV Treatment(First 24 postoperative hours)
- Patient Satisfaction(48 hours postoperatively (at hospital discharge).)
- Postoperative Complications(Periprocedurally, up to 48 hours postoperatively.)
研究者
Emanuel João Gonçalves Ferreira de Almeida
Consultant Anesthesiologist
Hospital dos Lusíadas