The Cortisol Levels During Cardiac Surgery. The Comparison Between Etomidate and Thiopentone
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|ClinicalTrials.gov Identifier: NCT01495949|
Recruitment Status : Completed
First Posted : December 20, 2011
Last Update Posted : May 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Valvular Heart Disease||Drug: etomidate Drug: thiopentone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Changes in Cortisol Levels and Stress Responses During Cardiac Surgery. The Comparison Between Two Induction Agents: Etomidate and Thiopentone.|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
|Active Comparator: 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||
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)
- 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).
- 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 ]
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
|Siriraj Hospital Mahidol University|
|Bangkok, Thailand, 10700|
|Principal Investigator:||Manee Raksakietisak, MD||Mahidol University|