Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06138041

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

intravenous lidocaine infusion

Drug

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.

Saline

Drug

Same volume of normal saline in bolus and continuous infusion as lidocaine group.

Primary outcomes

  1. 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

  1. respiratory infection

    Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery

  2. respiratory failure

    Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery

  3. pneumothorax;atelectasis

    Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery

  4. pleural effusion

    Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery

  5. bronchospasm

    Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery

  6. aspiration pneumonitis

    Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery

  7. anastomotic fistula

    Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery

  8. moderate to severe pain within 24 and 48 hours at rest and when coughing

    Time frame: 24 and 48 hours after surgery

  9. moderate to severe pain within 24 and 48 hours at coughing

    Time frame: 24 and 48 hours after surgery

  10. additional rescue analgesics use

    Time frame: 24 and 48 hours after surgery

Sponsors and collaborators

Lead sponsor

Sichuan Cancer Hospital and Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2023
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.