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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01495949
First Posted: December 20, 2011
Last Update Posted: May 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Manee Raksakietisak, Mahidol University
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Manee Raksakietisak, Mahidol University:

Primary Outcome Measures:
  • cortisol levels [ Time Frame: baseline (before induction), 2, 4, 8, and 24 hrs ]
    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 ]
    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 ]

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

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Manee Raksakietisak, Associate professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01495949     History of Changes
Other Study ID Numbers: Si559/2011
First Submitted: December 13, 2011
First Posted: December 20, 2011
Last Update Posted: May 23, 2014
Last Verified: May 2014

Keywords provided by Manee Raksakietisak, 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
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Etomidate
Thiopental
Anti-Inflammatory Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticonvulsants
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action