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

Primary Purpose

Coronary Artery Disease, Valvular Heart Disease

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
etomidate
thiopentone
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring etomidate, cortisol level, inotrope, cardiac patients

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Siriraj Hospital Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

etomidate

thiopentone

Arm Description

Outcomes

Primary Outcome Measures

cortisol levels
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
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

Full Information

First Posted
December 13, 2011
Last Updated
May 21, 2014
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01495949
Brief Title
The Cortisol Levels During Cardiac Surgery. The Comparison Between Etomidate and Thiopentone
Official Title
The Changes in Cortisol Levels and Stress Responses During Cardiac Surgery. The Comparison Between Two Induction Agents: Etomidate and Thiopentone.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Valvular Heart Disease
Keywords
etomidate, cortisol level, inotrope, cardiac patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
etomidate
Arm Type
Active Comparator
Arm Title
thiopentone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
etomidate
Other Intervention Name(s)
Etomidate Lipuro (B Braun company)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
thiopentone
Other Intervention Name(s)
Anesthal (Jagsonpal pharmaceuticals Ltd)
Intervention Description
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
Primary Outcome Measure Information:
Title
cortisol levels
Description
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).
Time Frame
baseline (before induction), 2, 4, 8, and 24 hrs
Secondary Outcome Measure Information:
Title
the use of inotropes for maintaining hemodynamic
Description
The dose and duration of inotropic drug (S) used for maintaining hemodynamic during coming off cardiopulmonary bypass and postoperative period.
Time Frame
24 hours
Title
Length of ICU and hospital stay
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manee Raksakietisak, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
26437535
Citation
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.
Results Reference
derived

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

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