Effect of Lidocaine Sprayed on Hemodynamics During Endotracheal Intubation

November 26, 2012 updated by: Hee-Pyoung Park, Seoul National University Hospital

Effect of Lidocaine Sprayed on Direct Laryngoscopy and Trachea on Hemodynamics During Endotracheal Intubation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Hee-Pyung Park, MD PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group L
10% Lidocaine was applied to the laryngoscope blade and 0.9% normal saline was applied to the trachea.
Drug: group L
10% Lidocaine was applied to the laryngoscope blade and 0.9% normal saline was applied to the trachea.
Placebo Comparator: group C
0.9% normal saline was applied to trachea and laryngoscope blade in Group C.
Drug: group C
0.9% normal saline was applied to trachea and laryngoscope blade
Experimental: group V
0.9% normal saline was applied to the laryngoscope blade and 10% Lidocaine was applied on trachea.
Drug: group V
0.9% normal saline was applied to the laryngoscope blade and 10% Lidocaine was applied on trachea.
Experimental: group LV
10% Lidocaine was applied on laryngoscope blade and trachea.
Drug: group LV
10% Lidocaine was applied on laryngoscope blade and trachea.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mean blood pressure, heart rate
Time Frame: baseline, at laryngoscope insertion, 60s after laryngoscope insertion, during intubation, one, two, three min after endotracheal intubation
baseline, at laryngoscope insertion, 60s after laryngoscope insertion, during intubation, one, two, three min after endotracheal intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

November 20, 2012

First Submitted That Met QC Criteria

November 26, 2012

First Posted (Estimate)

November 29, 2012

Study Record Updates

Last Update Posted (Estimate)

November 29, 2012

Last Update Submitted That Met QC Criteria

November 26, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • php1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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