Attenuation of the Hemodynamic Response to Double-lumen Endotracheal Intubation With Nebulized Lidocaine
1 other identifier
interventional
92
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2023
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2023
CompletedFirst Posted
Study publicly available on registry
May 9, 2023
CompletedStudy Start
First participant enrolled
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2025
CompletedMay 9, 2023
May 1, 2023
1.7 years
April 24, 2023
May 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mean arterial pressure after intubation
Immediately after intubation
Study Arms (2)
lidocaine
EXPERIMENTALIntervention group
saline
PLACEBO COMPARATORcontrol group
Interventions
Eligibility Criteria
You may qualify if:
- aged 18-65 years, American Society of Anesthesiologists class I-II
- participants undergoing double-lumen endotracheal intubation under general anesthesia
- signed informed consent and volunteered to participate in the experiment
You may not qualify if:
- Poor control of hypertension
- preoperative arrhythmia
- severe coronary artery or heart valve disease
- sequelae of cerebrovascular accident
- severe lung, liver, kidney and immune system diseases
- Suspected difficult airway
- confirmed or suspected allergy to this trial drug
- As judged by the investigator to be ineligible for the study, such as communication impairment (language or intelligence)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- 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
- attending physician
Study Record Dates
First Submitted
April 24, 2023
First Posted
May 9, 2023
Study Start
June 15, 2023
Primary Completion
March 9, 2025
Study Completion
September 9, 2025
Last Updated
May 9, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share