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Use of Lidocaine in Rapid Sequence Induction

This study has been completed.
Sponsor:
Information provided by:
University of Athens
ClinicalTrials.gov Identifier:
NCT01238718
First received: November 8, 2010
Last updated: August 23, 2011
Last verified: November 2010
History of Changes
  Purpose

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 Intervention
Hemodynamic Response
 Drug: Lidocaine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Impact of Lidocaine on Anesthetic Depth During Rapid Sequence Induction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Athens:

Primary Outcome Measures:
  • BIS changes after lidocaine administration in rapid sequence induction [ Time Frame: change from baseline in BIS values during 10 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in blood pressure [ Time Frame: change from baseline in blood pressure during 10 minutes ] [ Designated as safety issue: No ]
  • change in Heart rate [ Time Frame: change from baseline in heart rate durng 10 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: October 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: lidocaine Drug: Lidocaine
lidocaine 1.5 mg/kg intravenously
Placebo Comparator: normal saline Drug: Placebo
normal saline

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238718

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

No publications provided

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
Study First Received: November 8, 2010
Last Updated: August 23, 2011
Health Authority: Greece: Ethics Committee

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

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 21, 2013