Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

November 8, 2010
August 23, 2011
October 2008
July 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01238718 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Use of Lidocaine in Rapid Sequence Induction
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Hemodynamic Response
  • Drug: Lidocaine
    lidocaine 1.5 mg/kg intravenously
  • Drug: Placebo
    normal saline
  • Active Comparator: lidocaine
    Intervention: Drug: Lidocaine
  • Placebo Comparator: normal saline
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria :

Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01238718
lidocaine3
Not Provided
University of Athens, Chryssoula Staikou, 1st department of Anesthesiology, Aretaieio Hospital, University of Athens, Greece
University of Athens
Not Provided
Not Provided
University of Athens
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP