The Effect of Intraoperative Intravenous Lidocaine Infusion on Postoperative Pain and Recovery in Children (< 7 Years Old) Undergoing Thoracoscopic Surgery:Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- FLACC (ace, Legs, Activity, Cry, Consolability scale) Score
研究概览
简要总结
This study aims to investigate the efficacy of intraoperative intravenous lidocaine infusion on postoperative pain management and recovery in pediatric patients undergoing thoracoscopic pulmonary resection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged under 7 years undergoing thoracoscopic pulmonary resection
排除标准
- •cardiac dysfunction requiring vasopressors or inotropic agents
- •atrioventricular block or bradycardia
- •Liver or kidney dysfunction
- •Hypersensitivity to local anesthetics
研究组 & 干预措施
Lidocaine group
Anesthesia induction is performed according to the standard protocol. Monitoring includes electrocardiography, pulse oximetry, arterial blood pressure, depth of anesthesia (Patient State Index, PSI), and pain score (Analgesia Nociception Index).
In the lidocaine group, a single bolus dose of lidocaine 1.5 mg/kg is administered concurrently with the induction of anesthesia, followed by a continuous infusion of lidocaine at a rate of 1.5 mg/kg/hr.
干预措施: Lidocaine (drug) (Drug)
Control group
The control group receives a continuous infusion of normal saline in the same volume as that administered to the lidocaine group.
干预措施: Saline infusion (placebo) (Drug)
结局指标
主要结局
FLACC (ace, Legs, Activity, Cry, Consolability scale) Score
时间窗: up to 1 hour after surgery
Highest FLACC Score recorded in the postanesthesia care unit (The scale is scored in a range of 0-10 with 0 representing no pain.)
次要结局
- Remifentanil dose(throughout surgery (up to 3 hours))
- ANI (Analgesia Nociception Index)(throughout surgery (up to 3 hours))
- FLACC scores(6 hours, 12 hours, and 24 hours postoperatively)
- Total analgesic dosage administered postoperatively(up to 3 days after surgery)
- Postoperative complications(until discharge (up to 3-4 days after surgery))
研究者
Ji-Hyun Lee
Associate Professor
Seoul National University Hospital