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Not yet recruiting NCT06138041

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

No phase Interventional Postoperative Pneumonia Postoperative Pulmonary Atelectasis Postoperative Pulmonary Edema

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: intravenous lidocaine infusion, Saline.
Who it may be relevant to
Registry conditions: Postoperative Pneumonia, Postoperative Pulmonary Atelectasis, Postoperative Pulmonary Edema. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Incidence of PPCs [Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery]
Secondary outcome measures (10)
  • respiratory infection [Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery]
  • respiratory failure [Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery]
  • pneumothorax;atelectasis [Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery]
  • pleural effusion [Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery]
  • bronchospasm [Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery]
  • aspiration pneumonitis [Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery]
  • anastomotic fistula [Time frame: 1, 2, 3, 4, 5, 6, 7 days after surgery]
  • moderate to severe pain within 24 and 48 hours at rest and when coughing [Time frame: 24 and 48 hours after surgery]
  • moderate to severe pain within 24 and 48 hours at coughing [Time frame: 24 and 48 hours after surgery]
  • additional rescue analgesics use [Time frame: 24 and 48 hours after surgery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Wang F, Zhang H, Peng X, Liu M, Wang H, Song Y, Jia X, Zhu T, Zhu Y. Effect of intravenous lidocaine infusion on postoperative pulmonary complications in patients undergoing minimally invasive esophagectomy: a study protocol of double-center, double-blind, randomized controlled trial. Trials. 2025 Nov 11;26(1):490. doi: 10.1186/s13063-025-09213-x. PMID 41219803

Identifiers

NCT: NCT06138041 · scchec-20231113

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗