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

NCT06138041 | Not Yet Recruiting DMC

• 1 other identifier: scchec-20231113
• Study Type: interventional
• Target: 770
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pneumonia; Postoperative Pulmonary Atelectasis; Postoperative Pulmonary Edema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (2)

lidocaine group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

The control group will receive the same volume of normal saline in bolus and continuous infusion.

Drug: Saline

Interventions

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.

lidocaine group

Saline DRUG

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

control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: February 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: August 30, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share