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

Tracking Information
First Received Date ^ICMJE	November 8, 2010
Last Updated Date	August 23, 2011
Start Date ^ICMJE	October 2008
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 10, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01238718 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 10, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Use of Lidocaine in Rapid Sequence Induction
Official Title ^ICMJE	Impact of Lidocaine on Anesthetic Depth During Rapid Sequence Induction
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Condition ^ICMJE	Hemodynamic Response
Intervention ^ICMJE	Drug: Lidocaine lidocaine 1.5 mg/kg intravenously Drug: Placebo normal saline
Study Arm (s)	Active Comparator: lidocaine Intervention: Drug: Lidocaine Placebo Comparator: normal saline Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	76
Completion Date	July 2011
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: reason for rapid sequence induction (emergency, reflux), ASA I-II, no antihypertensive drugs, no antiarrhythmic drugs Exclusion Criteria :
Gender	Both
Ages	20 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Greece

Administrative Information
NCT Number ^ICMJE	NCT01238718
Other Study ID Numbers ^ICMJE	lidocaine3
Has Data Monitoring Committee	Not Provided
Responsible Party	University of Athens, Chryssoula Staikou, 1st department of Anesthesiology, Aretaieio Hospital, University of Athens, Greece
Study Sponsor ^ICMJE	University of Athens
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Athens
Verification Date	November 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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