The Analgesic Effect of Intravenous Lidocaine Infusion in Combination of Analgesia Nociception Index Monitoring in Spine Surgery.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- cumulative amount of opioids used
研究概览
简要总结
To evaluate the analgesic effect of intraoperative continuous lidocaine infusion (1.5 mg/kg/h (ideal body weight)) in combination of analgesia nociception index and depth of anesthesia monitors guided anesthetics adjustment on enhanced recovery after surgery (ERAS) in patients undergoing elective lumbar spine surgery (≥2 sessions).
详细描述
The patients undergoing elective lumbar spine surgery (≥2 sessions) are randomly assigned and divided patients into two groups according to the allocation sequence table (corresponding to 1:1 randomization) generated by the computer. Patients in the lidocaine group receive an intravenous injection of 1.5 mg/kg lidocaine at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation. Patients in control group receive the same volume of saline injection. During the operation, the dose of anesthetic drugs (propofol, remifentanil and rocuronium) are adjusted to maintain the mean arterial pressure and heartbeat fluctuations within 20% of the baseline value, Entropy (or BIS) value at 40-60, and ANI at 50-70 in both groups. The pain score (numerical rating scale), cumulative amount of opioids used after the operation within 3 days, and the quality of recovery on the third day after the operation are recorded and analyzed.
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, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Twenty to eighty-year-old
- •ASA class I-III patients undergoing
- •Elective lumbar spine surgery under general anesthesia
排除标准
- •Unable to understand the Numerical Rating Scale (NRS)
- •Severe mental disorder
- •Poor liver function
- •Pregnant or lactating women
- •Morbidly obese
- •History of epilepsy or allergy to any of the drugs used in this study
- •Current use of opioids
- •Baseline heart rate <50 beats/min
- •Arrhythmia history with cardiac rhythm device
- •Body weight <40 kg and >80kg
研究组 & 干预措施
lidocaine group
Patients in the lidocaine group receive an intravenous injection of 1.5 mg/kg Lidocaine HCl 2% at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation.
干预措施: Lidocaine HCl 2% (Drug)
control group
Patients in control group receive the same volume of saline injection.
干预措施: Normal saline (Drug)
结局指标
主要结局
cumulative amount of opioids used
时间窗: within 48 hours after operation
cumulative amount of opioids used after the operation
pain score
时间窗: within 72 hours after operation
numerical rating scale, NRS, 0-10, higher score means worse outcome
the quality of recovery after the operation
时间窗: on the third day after the operation
Quality of recovery-15 score, QoR-15, 0-150, higher score means better outcome
次要结局
- cumulative amount of remifentanil used(during operation)
- cumulative amount of opioids used(within 72 hours after operation)
- cumulative amount of propofol used(during operation)
- cumulative amount of rocuronium used(during operation)