Effect of Intravenous Lidocaine Infusion on Postoperative Pulmonary Complications in Patients Undergoing Minimally Invasive Esophagectomy: a Double-center, Double-blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 770
- 主要终点
- Incidence of PPCs
研究概览
简要总结
The goal of this double-center, double-blind, randomized controlled clinical trial is to compare the effect of intravenous lidocaine infusion on postoperative pulmonary complications in patients undergoing minimally invasive esophagectomy. The main question it aims to answer are whether intravenous lidocaine reduce postoperative pulmonary complications in patients undergoing minimally invasive esophagectomy. Participants will be given intravenous lidocaine infusion in lidocaine group or placebo in control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 85 years of age with a recent schedule for MIE are screened for this study. Patients who show clear consciousness and ASA status I - III will be included as eligible participants.
排除标准
- •The exclusion criteria are as follows: patients with severe psychiatric disorders, such as schizophrenia, depression, dementia, etc.; severe hepatic insufficiency (concentration of glutamic oxaloacetic transaminase, glutamic pyruvic transaminase or bilirubin ≥2.5 times the upper limit of normal); renal impairment (creatinine clearance <60 mL/min); allergy to amide local anesthetics; history of seizures; presence of II/III atrioventricular block; patients with severe sinus bradycardia or sick sinus syndrome; patients with Adams-Stokes syndrome or pre-excitation syndrome; intracardiac block (e.g. complete bundle branch block, atrioventricular block); serum potassium ion concentration below 2.5 or above 5.0 mmol/L; PH>7.55 or PH<7.
- •Patients will be discontinued if any of the following situations occur: the patient has an allergic reaction, severe cardiovascular events that cannot be managed with symptomatic treatment, and the patient is unwilling to continue the study.
研究组 & 干预措施
control group
The control group will receive the same volume of normal saline in bolus and continuous infusion.
干预措施: Saline (Drug)
lidocaine group
At the same time of induction of general anesthesia, an intravenous lidocaine bolus of 2mg/kg will be administered, followed by a continuous infusion of intravenous lidocaine at 2 mg/kg/h until the participate transfer out of postoperative anesthesia care unit.
干预措施: intravenous lidocaine infusion (Drug)
结局指标
主要结局
Incidence of PPCs
时间窗: 1, 2, 3, 4, 5, 6, 7 days after surgery
Pulmonary complications is defined as one or more of the following complications: respiratory infection; respiratory failure; pneumothorax;atelectasis; pleural effusion; bronchospasm; aspiration pneumonitis; anastomotic fistula
次要结局
- respiratory failure(1, 2, 3, 4, 5, 6, 7 days after surgery)
- respiratory infection(1, 2, 3, 4, 5, 6, 7 days after surgery)
- moderate to severe pain within 24 and 48 hours at rest and when coughing(24 and 48 hours after surgery)
- moderate to severe pain within 24 and 48 hours at coughing(24 and 48 hours after surgery)
- pleural effusion(1, 2, 3, 4, 5, 6, 7 days after surgery)
- bronchospasm(1, 2, 3, 4, 5, 6, 7 days after surgery)
- anastomotic fistula(1, 2, 3, 4, 5, 6, 7 days after surgery)
- pneumothorax;atelectasis(1, 2, 3, 4, 5, 6, 7 days after surgery)
- aspiration pneumonitis(1, 2, 3, 4, 5, 6, 7 days after surgery)
- additional rescue analgesics use(24 and 48 hours after surgery)
研究者
Yihao Zhu
Dr.
Sichuan Cancer Hospital and Research Institute