Effect of Lidocaine Sprayed on Hemodynamics During Endotracheal Intubation

NCT ID: NCT01737437

Last Updated: 2012-11-29

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A previous study demonstrated topical lidocaine spray on the larynx and the trachea is effective in reducing hemodynamic response to laryngoscopy and endotracheal intubation. In clinical practice, blind oropharyngeal application of lidocaine without aiding direct laryngoscopy can not assured that sprayed lidocaine effectively reaches the larynx and trachea. Therefore, direct laryngoscopy should be necessary to reach topical lidocaine to correct sites. Unfortunately, direct laryngoscopy itself can affect hemodynamics during spraying lidocaine. In this study, we will investigate an effect of lidocaine sprayed on direct laryngoscopy and the tracheal mucosa on hemodynamic change throughout intubation.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neurosurgical Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group L

10% Lidocaine was applied to the laryngoscope blade and 0.9% normal saline was applied to the trachea.

Group Type EXPERIMENTAL

group L

Intervention Type DRUG

10% Lidocaine was applied to the laryngoscope blade and 0.9% normal saline was applied to the trachea.

group C

0.9% normal saline was applied to trachea and laryngoscope blade in Group C.

Group Type PLACEBO_COMPARATOR

group C

Intervention Type DRUG

0.9% normal saline was applied to trachea and laryngoscope blade

group V

0.9% normal saline was applied to the laryngoscope blade and 10% Lidocaine was applied on trachea.

Group Type EXPERIMENTAL

group V

Intervention Type DRUG

0.9% normal saline was applied to the laryngoscope blade and 10% Lidocaine was applied on trachea.

group LV

10% Lidocaine was applied on laryngoscope blade and trachea.

Group Type EXPERIMENTAL

group LV

Intervention Type DRUG

10% Lidocaine was applied on laryngoscope blade and trachea.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

group C

0.9% normal saline was applied to trachea and laryngoscope blade

Intervention Type DRUG

group L

10% Lidocaine was applied to the laryngoscope blade and 0.9% normal saline was applied to the trachea.

Intervention Type DRUG

group V

0.9% normal saline was applied to the laryngoscope blade and 10% Lidocaine was applied on trachea.

Intervention Type DRUG

group LV

10% Lidocaine was applied on laryngoscope blade and trachea.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* aged 20-60 years,
* ASA groups I or II

Exclusion Criteria

* ASA III or IV,
* hypertension,
* anticipated difficult airway, and
* severe coronary and cerebrovascular diseases
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hee-Pyoung Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

SUE YOUNG LEE, MD

Role: CONTACT

Phone: 82-10-9700-6509

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hee-Pyoung PARK, MD PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

php1

Identifier Type: -

Identifier Source: org_study_id