NCT05850702

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2023

Typical duration for phase_4

Status
unknown

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

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2025

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

1.7 years

First QC Date

April 24, 2023

Last Update Submit

May 6, 2023

Conditions

Keywords

Double-lumen Endotracheal Intubation

Outcome Measures

Primary Outcomes (1)

  • mean arterial pressure after intubation

    Immediately after intubation

Study Arms (2)

lidocaine

EXPERIMENTAL

Intervention group

Drug: Lidocaine

saline

PLACEBO COMPARATOR

control group

Drug: Saline

Interventions

inhale 5ml of 2% lidocaine by nebulization

lidocaine
SalineDRUG

inhale 5ml of saline by nebulization

saline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

MeSH Terms

Conditions

Lung Neoplasms

Interventions

LidocaineSodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

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