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

• Sponsor: RenJi Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05850702
• Collaborator: (none)
• Enrollment: 92
• Arms: 2
• Anticipated Duration (Months): 26.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasms	Drug: Lidocaine; Drug: Saline	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Attenuation of the Hemodynamic Response to Double-lumen Endotracheal Intubation With Nebulized Lidocaine: a Randomized, Double-blind, Controlled Trial
• Anticipated Study Start Date: Jun 15, 2023
• Anticipated Primary Completion Date: Mar 9, 2025
• Anticipated Study Completion Date: Sep 9, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. mean arterial pressure after intubation [Immediately after intubation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• RenJi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: zhuhao, attending physician, RenJi Hospital
• ClinicalTrials.gov Identifier: NCT05850702
• Other Study ID Numbers: IIT-2022-0250
• First Posted: May 9, 2023
• Last Update Posted: May 9, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by zhuhao, attending physician, RenJi Hospital: Double-lumen Endotracheal Intubation
• Additional relevant MeSH terms: Lung Neoplasms; Lidocaine

Study Results

No Results Posted as of May 9, 2023