- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01238718
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
-
-
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
|
lidocaine 1.5 mg/kg intravenously
|
PLACEBO_COMPARATOR: normal saline
|
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
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
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
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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