A Randomized Double-Blind Trial Comparing Lidocaine and Dexmedetomidine Infusion and Their Combination on Perioperative Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Total morphine consumption
研究概览
简要总结
This study aims to compare lidocaine and dexmedetomidine infusion and their combination on perioperative pain in patients undergoing video-assisted thoracoscopic surgery.
详细描述
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive procedure allowing the reduction of surgical stress. However, postoperative pain management is crucial for patients undergoing VATS, as inadequate pain control can lead to complications (such as lung atelectasis), prolonged recovery, and decreased patient satisfaction.
Dexmedetomidine has shown positive effects on postoperative pain intensity, opioid consumption and other recovery parameters, such as postoperative nausea and vomiting (PONV), and speed of recovery.
Lidocaine has exhibited an excellent safety profile when administered as a low-dose infusion for cancer or non-cancer chronic pain.
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
- Double (Participant, Outcomes Assessor)
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 old.
- •Both sexes.
- •American Society of Anesthesiologists (ASA) physical status of I, II.
- •Patients undergoing video-assisted thoracoscopic surgery (VATS) under general anesthesia.
排除标准
- •Hypersensitivity to any of the used drugs.
- •Coagulation disorder.
- •Body mass index >35 kg/m
- •History of chronic pain requiring daily opioids/steroids/clonidine/other α2 agonist/analgesics or any drugs acting on the central nervous system during the previous 2 weeks, and drug/alcohol abuse.
- •Contraindication to the use of local anesthetics.
- •Cardiovascular disease.
- •Severe respiratory, renal or hepatic impairment.
- •Insulin-dependent diabetes mellitus.
- •Central nervous system or psychiatric disease.
研究组 & 干预措施
Dexmedetomidine group
Patients will receive dexmedetomidine 0.5 μg/kg infusion over 10 min as a loading dose then 0.5 μg/kg/h after induction of anesthesia as maintenance dose till 10 min before the end of the operation plus saline 0.9% with same rate of lidocaine.
干预措施: Dexmedetomidine (Drug)
Lidocaine group
Patients will receive lidocaine 0.3 mg/kg over 10 min loading, 0.3 mg/kg/h infusion after induction of anesthesia as maintenance dose till 10 min before the end of the operation plus saline 0.9% with same rate of dexmedetomidine
干预措施: Lidocaine (Drug)
Lidocaine and Dexmedetomidine group
Patients will receive lidocaine (0.3 mg/kg in 10 min loading, 0.3 mg/kg/h infusion) and dexmedetomidine infusions (0.5 μg/kg infusion over 10 min as a loading dose then 0.5 μg/kg/h) till 10 min before the end of the operation.
干预措施: Lidocaine and Dexmedetomidine (Drug)
结局指标
主要结局
Total morphine consumption
时间窗: 24 hours postoperatively
Rescue analgesia of morphine will be given as 3 mg bolus if the Visual Analogue Scale (VAS)\> 3 to be repeated after 30 min if pain persists until the VAS \< 4.
次要结局
- Time of extubation(24 hours postoperatively)
- Time to the first request for the rescue analgesia(24 hours postoperatively)
- Degree of pain(24 hours postoperatively)
- Degree of patient satisfaction(24 hours postoperatively)
- Incidence of adverse events(24 hours postoperatively)
研究者
Sarah Ahmed
Lecturer of Anesthesia, Intensive care, and pain management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Ain Shams University