The Cortisol Levels During Cardiac Surgery. The Comparison Between Etomidate and Thiopentone
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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. |
- 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).
- 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 CPB and postoperative peroid.
- Length of ICU and hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 92 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 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 |
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| Contact: Manee Raksakietisak, MD | 6624197990 | simrs@mahidol.ac.th |
| Thailand | |
| Siriraj Hospital Mahidol University | Recruiting |
| Bangkok, Thailand, 10700 | |
| Contact: Manee Raksakietisak, MD 6624197990 simrs@mahidol.ac.th | |
| Principal Investigator: Manee Raksakietisak, MD | |
| 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: | July 16, 2012 |
| 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 May 21, 2013