Intravenous Lidocaine Infusion Reduce Postoperative Pulmonary Complications in Patients Undergoing Minimally Invasive Esophagectomy

Study Overview
=================
Brief Summary
-----------------
The goal of this multicenter, 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.

Official Title
-----------------
Effect of Intravenous Lidocaine Infusion on Postoperative Pulmonary Complications in Patients Undergoing Minimally Invasive Esophagectomy: a Multicenter, Double-blind, Randomized Controlled Trial

Conditions
-----------------
Postoperative Pneumonia, Postoperative Pulmonary Atelectasis, Postoperative Pulmonary Edema

Intervention / Treatment
-----------------
* Drug: intravenous lidocaine infusion
* Drug: Saline


Participation Criteria
=================
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<7.2. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lidocaine group<br>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. | Drug: intravenous lidocaine infusion<br>* Lidocaine bolus of 2mg/kg after induction , and then continuous infusion with 2 mg/kg/h until the participate transfer out of postoperative anesthesia care unit.<br>|
| Placebo Comparator: control group<br>The control group will receive the same volume of normal saline in bolus and continuous infusion. | Drug: Saline<br>* Same volume of normal saline in bolus and continuous infusion as lidocaine group.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of PPCs | 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 | 1, 2, 3, 4, 5, 6, 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory infection |  | 1, 2, 3, 4, 5, 6, 7 days after surgery | 
| respiratory failure |  | 1, 2, 3, 4, 5, 6, 7 days after surgery | 
| pneumothorax;atelectasis |  | 1, 2, 3, 4, 5, 6, 7 days 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 | 
| aspiration pneumonitis |  | 1, 2, 3, 4, 5, 6, 7 days after surgery | 
| anastomotic fistula |  | 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 | 
| additional rescue analgesics use |  | 24 and 48 hours after surgery |