Attenuation of the Hemodynamic Response to Double-lumen Endotracheal Intubation With Nebulized Lidocaine

May 6, 2023 updated by: zhuhao, RenJi Hospital

Attenuation of the Hemodynamic Response to Double-lumen Endotracheal Intubation With Nebulized Lidocaine: a Randomized, Double-blind, Controlled Trial

The goal of this clinical trial is to test the effect of nebulized lidocaine on the hemodynamic response in the participant undergoing double-lumen endotracheal intubation.

The main question it aims to answer is to evaluate the changes in mean arterial pressure after intubation.

Participants will inhale 5ml of 2% lidocaine by nebulization15min before intubation.

Researchers will compare saline group to see if saline effects

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

92

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. aged 18-65 years, American Society of Anesthesiologists class I-II
  2. participants undergoing double-lumen endotracheal intubation under general anesthesia
  3. signed informed consent and volunteered to participate in the experiment

Exclusion Criteria:

  1. Poor control of hypertension
  2. preoperative arrhythmia
  3. severe coronary artery or heart valve disease
  4. sequelae of cerebrovascular accident
  5. severe lung, liver, kidney and immune system diseases
  6. Suspected difficult airway
  7. confirmed or suspected allergy to this trial drug
  8. As judged by the investigator to be ineligible for the study, such as communication impairment (language or intelligence)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: saline
control group
Drug: Saline
inhale 5ml of saline by nebulization
Experimental: lidocaine
Intervention group
Drug: Lidocaine
inhale 5ml of 2% lidocaine by nebulization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mean arterial pressure after intubation
Time Frame: Immediately after intubation
Immediately after intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 15, 2023

Primary Completion (Anticipated)

March 9, 2025

Study Completion (Anticipated)

September 9, 2025

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

May 6, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 6, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-2022-0250

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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