Use of Lidocaine in Rapid Sequence Induction

August 23, 2011 updated by: University of Athens

Impact of Lidocaine on Anesthetic Depth During Rapid Sequence Induction

Lidocaine has been shown to blunt the cardiovascular response to endotracheal intubation. The incidence of hypertension, tachycardia and dysrhythmias due to laryngoscopy may be increased in patients that receive rapid sequence induction and intubation, where opioids are spared and intravenous anesthetic agents are not titrated step by step. Our hypothesis was that lidocaine when administered intravenously in patients who undergo rapid sequence induction may not only blunt the hemodynamic response to intubation, but may also increase the anesthetic depth (as assessed by BIS), thus further reducing the possibility of hypertension, arrhythmias and also awareness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

76

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

  • Greece
    • Attiki
      • Athens, Attiki, Greece, 11528
        • Aretaieio Hospital, University of Athens

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 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • reason for rapid sequence induction (emergency, reflux),
  • ASA I-II,
  • no antihypertensive drugs,
  • no antiarrhythmic drugs

Exclusion Criteria :

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

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: lidocaine
Drug: Lidocaine
lidocaine 1.5 mg/kg intravenously
PLACEBO_COMPARATOR: normal saline
Drug: Placebo
normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BIS changes after lidocaine administration in rapid sequence induction
Time Frame: change from baseline in BIS values during 10 minutes
change from baseline in BIS values during 10 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
change in blood pressure
Time Frame: change from baseline in blood pressure during 10 minutes
change from baseline in blood pressure during 10 minutes
change in Heart rate
Time Frame: change from baseline in heart rate durng 10 minutes
change from baseline in heart rate durng 10 minutes

Collaborators and Investigators

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

Sponsor

University of Athens

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, 2008

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

November 10, 2010

First Posted (ESTIMATE)

November 11, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 24, 2011

Last Update Submitted That Met QC Criteria

August 23, 2011

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lidocaine3

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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