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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pneumonia; Postoperative Pulmonary Atelectasis; Postoperative Pulmonary Edema
• Intervention / Treatment: Drug: intravenous lidocaine infusion; Drug: Saline

• Study Type: Interventional
• Enrollment (Estimated): 770
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: intravenous lidocaine infusion; 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.
Placebo Comparator: control group; The control group will receive the same volume of normal saline in bolus and continuous infusion.	Drug: Saline; Same volume of normal saline in bolus and continuous infusion as lidocaine group.

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	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

Collaborators and Investigators

• Sponsor: Sichuan Cancer Hospital and Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Estimated): November 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis; Pulmonary Edema; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: scchec-20231113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No