Effect of Intravenous Lidocaine Infusion on Postoperative Pulmonary Complications in Patients Undergoing Minimally Invasive Esophagectomy: a Double-center, Double-blind, Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Saline
- Conditions
- Postoperative Pneumonia
- Sponsor
- Sichuan Cancer Hospital and Research Institute
- Enrollment
- 770
- Primary Endpoint
- Incidence of PPCs
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Yihao Zhu
Dr.
Sichuan Cancer Hospital and Research Institute
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
control group
The control group will receive the same volume of normal saline in bolus and continuous infusion.
Intervention: Saline
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.
Intervention: intravenous lidocaine infusion
Outcomes
Primary Outcomes
Incidence of PPCs
Time Frame: 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
Secondary Outcomes
- 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)