NCT01386229

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 1, 2011

Status Verified

June 1, 2011

Enrollment Period

9 months

First QC Date

June 21, 2011

Last Update Submit

June 30, 2011

Conditions

Coronary Artery Bypass Surgery

Keywords

hemodynamic stabilityetomidateketaminecoronary artery bypass surgery after induction of anesthesia, hemodynamic stability

Outcome Measures

Primary Outcomes (1)

  • A more than 15% change in mean arterial pressure and heart rate after anesthesia induction

    For 60 minutes after anesthesia induction

Secondary Outcomes (1)

  • Adrenal gland steroid synthesis suppression

    24 hours and 5 days after study drug administration

Study Arms (2)

Ketamine

ACTIVE COMPARATOR
Drug: Ketamine

Etomidate

ACTIVE COMPARATOR
Drug: Etomidate

Interventions

KetamineDRUG

During standard anesthesia induction with fentanyl and midazolam, ketamine 2 mg/kg IV will be administered

Ketamine
EtomidateDRUG

During standard anesthesia induction with fentanyl and midazolam, etomidate 3 mg/kg IV will be administered

Etomidate

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Allergy to study drugs
  • Redo surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University, Faculty of Medicine

Ankara, Çankaya, 06490, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

KetamineEtomidate

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Özgür Kömürcü

    Baskent University, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Özgür Kömürcü

CONTACT

+90 312 215 99 41zgrkom@gmail.com

Arash Pirat

CONTACT

+90 312 212 68 68araspirat@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 21, 2011

First Posted

July 1, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Study Completion

March 1, 2012

Last Updated

July 1, 2011

Record last verified: 2011-06

Locations

TU(1)