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

• ClinicalTrials.gov Identifier: NCT01495949
• Recruitment Status: Completed
• First Posted: December 20, 2011
• Last Update Posted: May 23, 2014
• Sponsor: Mahidol University
• Information provided by (Responsible Party): Manee Raksakietisak, Mahidol University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Coronary Artery Disease; Valvular Heart Disease	Drug: etomidate; Drug: thiopentone	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 92 participants
• 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.
• Study Start Date: December 2011
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.
2. Length of ICU and hospital stay [ Time Frame: 30 days ]

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 85 Years (Adult, Older Adult)
• 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

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):

Raksakietisak M, Ngamlamiad C, Duangrat T, Soontarinka S, Raksamani K. The Changes in Cortisol Levels during Cardiac Surgery: A Randomized Double-Blinded Study between Two Induction Agents Etomidate and Thiopentone. J Med Assoc Thai. 2015 Aug;98(8):775-81.

• Responsible Party: Manee Raksakietisak, Associate professor, Mahidol University
• ClinicalTrials.gov Identifier: NCT01495949
• Other Study ID Numbers: Si559/2011
• 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; Heart Diseases; Heart Valve Diseases; Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Thiopental; Etomidate; 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