Use of Lidocaine in Rapid Sequence Induction | NCT01238718

Studies
Use of Lidocaine in Rapid Sequence Induction

NCT01238718

Sponsor

University of Athens

Status

Completed

Last Update Posted

Aug 24, 2011Estimated

Enrollment

76Estimated

Phase

Not Applicable

Conditions

Hemodynamic Response

Interventions

Lidocaine
Placebo

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Nov 8, 2010

First Submission Date that Met QC Criteria

Nov 10, 2010

First Posted Date

Nov 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2011

Last Update Posted Date

Aug 24, 2011Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lidocaine	Active Comparator		Drug: Lidocaine
normal saline	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine	Drug	lidocaine 1.5 mg/kg intravenously	lidocaine
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BIS changes after lidocaine administration in rapid sequence induction		change from baseline in BIS values during 10 minutes

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria :

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aretaieio Hospital, University of Athens		Athens	Attica	11528	Greece

Type	Date	Date Unknown
Release	Mar 30, 2012
Reset	Apr 24, 2012
Release	May 11, 2012
Reset	Jun 11, 2012
Release	Jun 14, 2012
Reset	Jul 18, 2012
Release	Jan 21, 2013
Reset	Feb 22, 2013
Release	Oct 9, 2018
Reset	Feb 18, 2019
Release	Feb 18, 2019
Reset	May 30, 2019

Submission Tracking

Estimated Results First Submitted Date

Mar 30, 2012

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 30, 2012			Apr 24, 2012
May 11, 2012

Intervention Browse Module

MeSH Terms

ID	Term
D008012	Lidocaine

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

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Browse Branches

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