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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01238718
Other study ID # lidocaine3
Secondary ID
Status Completed
Phase N/A
First received November 8, 2010
Last updated August 23, 2011
Start date October 2008
Est. completion date July 2011

Study information

Verified date November 2010
Source University of Athens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- reason for rapid sequence induction (emergency, reflux),

- ASA I-II,

- no antihypertensive drugs,

- no antiarrhythmic drugs

Exclusion Criteria :

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lidocaine
lidocaine 1.5 mg/kg intravenously
Placebo
normal saline

Locations

Country Name City State
Greece Aretaieio Hospital, University of Athens Athens Attiki

Sponsors (1)

Lead Sponsor Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary BIS changes after lidocaine administration in rapid sequence induction change from baseline in BIS values during 10 minutes
Secondary change in blood pressure change from baseline in blood pressure during 10 minutes
Secondary change in Heart rate change from baseline in heart rate durng 10 minutes
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