A Comparison of Etomidate and Ketamine for Anesthesia Ind... | NCT01386229

Studies
A Comparison of Etomidate and Ketamine for Anesthesia Induction in Coronary Artery Bypass Graft Surgery

NCT01386229

Sponsor

Baskent University

Status

Unknown status

Last Update Posted

Jul 1, 2011Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Coronary Artery Bypass Surgery

Interventions

Ketamine
Etomidate

Countries

Turkey (Türkiye)

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Dec 2011Estimated

Completion Date

Mar 2012Estimated

First Submitted Date

Jun 21, 2011

First Submission Date that Met QC Criteria

Jun 30, 2011

First Posted Date

Jul 1, 2011Estimated

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

Jun 30, 2011

Last Update Posted Date

Jul 1, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to determine whether ketamine is an acceptable alternative to etomidate for anesthesia induction in coronary artery bypass graft surgery in terms of hemodynamic stability and also to compare these agents regarding their effect on adrenal gland steroid synthesis in these patients.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ketamine	Active Comparator		Drug: Ketamine
Etomidate	Active Comparator		Drug: Etomidate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ketamine	Drug	During standard anesthesia induction with fentanyl and midazolam, ketamine 2 mg/kg IV will be administered	Ketamine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
A more than 15% change in mean arterial pressure and heart rate after anesthesia induction		For 60 minutes after anesthesia induction

Secondary Outcomes

Measure	Description	Time Frame
Adrenal gland steroid synthesis suppression	A less than 9 microgram/dl increase in serum cortisol after stimulation with adrenocorticotropic hormone	24 hours and 5 days after study drug administration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled for elective coronary artery bypass graft surgery with cardiopulmonary bypass
Patient's written informed consent for study participation
Ejection fraction ≥ 35%

Exclusion Criteria:

Allergy to study drugs
Redo surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Özgür Kömürcü	Contact	+90 312 215 99 41		zgrkom@gmail.com
Arash Pirat	Contact	+90 312 212 68 68	1800	araspirat@gmail.com

Overall Officials

Name	Affiliation	Role
Özgür Kömürcü	Baskent University, Faculty of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baskent University, Faculty of Medicine	Recruiting	Ankara	Çankaya	06490	Turkey (Türkiye)

Intervention Browse Module

MeSH Terms

ID	Term
D007649	Ketamine
D005045	Etomidate

Ancestor Terms

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic

Browse Leaves

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Browse Branches

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