Use of Lidocaine in Rapid Sequence Induction

• Sponsor: University of Athens (Other)
• Overall Status: Completed
• CT.gov ID: NCT01238718
• Collaborator: (none)
• Enrollment: 76
• Location: 1
• Arms: 2
• Duration (Months): 33
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodynamic Response	Drug: Lidocaine; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Official Title: Impact of Lidocaine on Anesthetic Depth During Rapid Sequence Induction
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: lidocaine	Drug: Lidocaine; lidocaine 1.5 mg/kg intravenously
Placebo Comparator: normal saline	Drug: Placebo; normal saline

Outcome Measures

Primary Outcome Measures

1. BIS changes after lidocaine administration in rapid sequence induction [change from baseline in BIS values during 10 minutes]

Secondary Outcome Measures

1. change in blood pressure [change from baseline in blood pressure during 10 minutes]

2. change in Heart rate [change from baseline in heart rate durng 10 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

• ASA I-II,

• no antihypertensive drugs,

• no antiarrhythmic drugs

Exclusion Criteria :

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aretaieio Hospital, University of Athens	Athens	Attiki	Greece	11528

Sponsors and Collaborators

• University of Athens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01238718
• Other Study ID Numbers: lidocaine3
• First Posted: Nov 11, 2010
• Last Update Posted: Aug 24, 2011
• Last Verified: Nov 1, 2010

• Keywords provided by , ,: lidocaine; anesthetic depth; hemodynamics; rapid sequence induction; BIS
• Additional relevant MeSH terms: Lidocaine

Study Results

No Results Posted as of Aug 24, 2011