The Cortisol Levels During Cardiac Surgery. The Comparison Between Etomidate and Thiopentone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Manee Raksakietisak, Mahidol University
ClinicalTrials.gov Identifier:
NCT01495949
First received: December 13, 2011
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

During induction for cardiac surgery, patient hemodynamic stability is achieved by using anesthetic drugs which least affects hemodynamics such as benzodiazepines, etomidate. Etomidate although has been used for a long time but its safety regarding cortisol synthesis suppression is still doubtful. This study measures the changes in cortisol levels during cardiac surgery with the use of cardiopulmonary bypass by comparison between two inductive agents (etomidate and thiopentone). Recording data also include hemodynamic changes during induction, inotropic use for coming of cardiopulmonary bypass, blood glucose levels, amount of insulin usage, length of ICU and hospital saty.


Condition Intervention Phase
Coronary Artery Disease
Valvular Heart Disease
Drug: etomidate
Drug: thiopentone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Changes in Cortisol Levels and Stress Responses During Cardiac Surgery. The Comparison Between Two Induction Agents: Etomidate and Thiopentone.

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • cortisol levels [ Time Frame: baseline (before induction), 2, 4, 8, and 24 hrs ] [ Designated as safety issue: Yes ]
    Measure cortisol levels and its changes due to stress response during surgery. Compare the changes in cortisol levels between two induction agents (etomidate and thiopentone).


Secondary Outcome Measures:
  • the use of inotropes for maintaining hemodynamic [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    The dose and duration of inotropic drug (S) used for maintaining hemodynamic during coming off cardiopulmonary bypass and postoperative period.

  • Length of ICU and hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: December 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: etomidate Drug: etomidate
During induction, after 3 mcg/kg of fentanyl and 0.05 mg/kg of midazolam given, small doses 2-4 mg (1-2 ml) of etomidate will be given by titration (the syringe pump and extension and three way stopcock are covered to blind the study drug) until the patients are unconscious.
Other Name: Etomidate Lipuro (B Braun company)
Active Comparator: thiopentone Drug: thiopentone
During induction, after 3 mcg/kg of fentanyl and 0.05 mg/kg of midazolam given, small doses 25-50 mg (1-2 ml) of thiopentone will be given by titration (the syringe pump and extension and three way stopcock are covered to blind the study drug) until the patients are unconscious
Other Name: Anesthal (Jagsonpal pharmaceuticals Ltd)

Detailed Description:

Ninety-two cardiac patients who undergoing cardiopulmonary bypass graft (CABG) or valve surgery will be enrolled in this study. They will be randomized into two groups (thiopentone and etomidate groups). Apart from different in two inductive drugs, other anesthetics will be the same. We record hemodynamic changes during inductions, inotropic use (dose and duration), blood glucose levels, total insulin requirement to keep blood glucose 140-180 mg% in perioperative period, duration of mechanical ventilation, length of stay in ICU and total hospital length of stay. The changes in cortisol levels will be recorded at time 0 (before induction), 2, 4, 8, 24 hours in 26 patients (13 patients in each group and only patients who are the first in the operating list (morning list)).The 26 patients is needed from sample size equation for the changes in cortisol level and the 92 patients is calculated from the differences in inotropic use.

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

60 year or older cardiac patient undergoing cardiac surgery (CABG or valve surgery) with the use of cardiopulmonary bypass -

Exclusion Criteria:

  • Redo or emergency operation
  • complex and prolong operation
  • history of adrenal insufficiency or steroid use
  • already has inotropic drugs to support hemodynamics
  • creatinine > 2.0 mg/dl
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01495949

Locations
Thailand
Siriraj Hospital Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Manee Raksakietisak, MD Mahidol University
  More Information

No publications provided

Responsible Party: Manee Raksakietisak, Associate professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01495949     History of Changes
Other Study ID Numbers: Si559/2011
Study First Received: December 13, 2011
Last Updated: May 21, 2014
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
etomidate
cortisol level
inotrope
cardiac patients

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Etomidate
Thiopental
Hydrocortisone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anti-Inflammatory Agents
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants

ClinicalTrials.gov processed this record on July 24, 2014