We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of Lidocaine in Rapid Sequence Induction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01238718
Recruitment Status : Completed
First Posted : November 11, 2010
Last Update Posted : August 24, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Hemodynamic Response Drug: Lidocaine Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Impact of Lidocaine on Anesthetic Depth During Rapid Sequence Induction
Study Start Date : October 2008
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: lidocaine Drug: Lidocaine
lidocaine 1.5 mg/kg intravenously
Placebo Comparator: normal saline Drug: Placebo
normal saline


Outcome Measures

Primary Outcome Measures :
  1. BIS changes after lidocaine administration in rapid sequence induction [ Time Frame: change from baseline in BIS values during 10 minutes ]

Secondary Outcome Measures :
  1. change in blood pressure [ Time Frame: change from baseline in blood pressure during 10 minutes ]
  2. change in Heart rate [ Time Frame: change from baseline in heart rate durng 10 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria :

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238718


Locations
Greece
Aretaieio Hospital, University of Athens
Athens, Attiki, Greece, 11528
Sponsors and Collaborators
University of Athens
More Information

Responsible Party: University of Athens, Chryssoula Staikou, 1st department of Anesthesiology, Aretaieio Hospital, University of Athens, Greece
ClinicalTrials.gov Identifier: NCT01238718     History of Changes
Other Study ID Numbers: lidocaine3
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: August 24, 2011
Last Verified: November 2010

Keywords provided by University of Athens:
lidocaine
anesthetic depth
hemodynamics
rapid sequence induction
BIS

Additional relevant MeSH terms:
Lidocaine
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action