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

NCT ID: NCT06138041

Last Updated: 2024-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

770 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pneumonia Postoperative Pulmonary Atelectasis Postoperative Pulmonary Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

intravenous lidocaine infusion

Intervention Type 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.

control group

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Yihao Zhu

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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scchec-20231113

Identifier Type: -

Identifier Source: org_study_id

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