NCT01238718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

August 24, 2011

Status Verified

November 1, 2010

Enrollment Period

2.7 years

First QC Date

November 8, 2010

Last Update Submit

August 23, 2011

Conditions

Hemodynamic Response

Keywords

lidocaineanesthetic depthhemodynamicsrapid sequence inductionBIS

Outcome Measures

Primary Outcomes (1)

  • BIS changes after lidocaine administration in rapid sequence induction

    change from baseline in BIS values during 10 minutes

Secondary Outcomes (2)

  • change in blood pressure

    change from baseline in blood pressure during 10 minutes

  • change in Heart rate

    change from baseline in heart rate durng 10 minutes

Study Arms (2)

lidocaine

ACTIVE COMPARATOR
Drug: Lidocaine

normal saline

PLACEBO COMPARATOR
Drug: Placebo

Interventions

LidocaineDRUG

lidocaine 1.5 mg/kg intravenously

lidocaine
PlaceboDRUG

normal saline

normal saline

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aretaieio Hospital, University of Athens

Athens, Attica, 11528, Greece

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 8, 2010

First Posted

November 11, 2010

Study Start

October 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

August 24, 2011

Record last verified: 2010-11

Locations

GR(1)