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

NCT ID: NCT05850702

Last Updated: 2023-05-09

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2025-09-09

Brief Summary

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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

Detailed Description

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Conditions

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Lung Neoplasms

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

Intervention group

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

inhale 5ml of 2% lidocaine by nebulization

saline

control group

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

inhale 5ml of saline by nebulization

Interventions

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Lidocaine

inhale 5ml of 2% lidocaine by nebulization

Intervention Type DRUG

Saline

inhale 5ml of saline by nebulization

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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zhuhao

attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Hao Zhu

Role: CONTACT

008602168383702

Other Identifiers

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IIT-2022-0250

Identifier Type: -

Identifier Source: org_study_id

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