Comparison of Lidocaine, Dexmedetomidine and Ketamine in Multimodal Analgesia Management Following Sleeve Gastrectomy Surgery: A Randomized Double-Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Postoperative pain: VAS scores at rest and movement
研究概览
简要总结
Following laparoscopic bariatric surgery, multimodal analgesia is recommended to avoid the adverse effects of opioids by reducing their use. Although lidocaine, ketamine, and dexmedetomidine have been used as adjuvant analgesics, no studies have evaluated the superiority of their intra- and postoperative infusions as components of multimodal analgesia in bariatric surgery. The present study is aimed to compare lidocaine, dexmedetomidine, and ketamine in multimodal analgesia management following Sleeve Gastrectomy Surgery. Postoperative pain scores, the requirement for additional postoperative analgesia, retching, nausea and vomiting, time to mobilization, and hospital length of stay will be evaluated.
详细描述
Patients will be divided into three groups.
Group L: The patients will receive intravenous lidocaine (2 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 1 mg/kg/h. The infusion will continue until 12 hours after the operation.
Group K: The patients will receive intravenous ketamine (0.5 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 0.3 mg/kg/h. The infusion will continue until 12 hours after the operation.
Group D: The patients will receive intravenous dexmedetomidine (0.5 mg/kg/h) immediately after anesthesia induction. At the end of the surgery, the dose will be decreased to 0.3 mg/kg/h. The infusion will continue until 12 hours after the operation.
Ketamine, lidocaine, and dexmedetomidine doses will be calculated according to ideal body weight, lean body weight, and actual body weight, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Drugs to be used will be prepared 30 minutes before the surgery in the drug preparation room by a nurse who is not involved in the study. Investigators and patients will be blinded to the group assignments.
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
- •Body mass index>35 kg/m2
- •The American Society of Anaesthesiologists (ASA) physical status class II III
- •Patients who will undergo an elective laparoscopic sleeve gastrectomy (LSG)
排除标准
- •refusal to participate
- •allergy to the study drugs
- •chronic kidney disease (creatinine>150 μmol/L)
- •mental illness
- •liver, respiratory or oncological disease,
- •cardiac dysfunction (ejection fraction <40%),
- •uncontrolled hypertension,
- •preoperative analgesic use,
- •chronic pain,
- •history of alcohol or drug addiction
研究组 & 干预措施
Group L
IV lidocaine infusion (1-2 mg/kg/h) up to postoperative 12 hours.
干预措施: Lidocain (Drug)
Group K
IV ketamine infusion (0.3-0.5 mg/kg/h) up to postoperative 12 hours.
干预措施: Ketamine (Drug)
Group D
IV dexmedetomidine infusion (0.3-0.5 mg/kg/h) up to postoperative 12 hours.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Postoperative pain: VAS scores at rest and movement
时间窗: Up to 15 days after the surgery.
Pain status at rest and movement will be assessed by VAS scores. The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (worst pain imaginable).
次要结局
- Time to first mobilization(Up to 24 hours after surgery.)
- Postoperative Rescue Analgesic Requirement(Up to three days after surgery)
- Postoperative nausea, retching and vomiting(Up to 3 days after surgery.)
- Time to discharge(Trough hospital stay, an average of 1 week.)
研究者
Yasemin Burcu Ustun
Associate Professor
Ondokuz Mayıs University