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

NCT01495949 | Completed Phase 4

• 1 other identifier: Si559/2011
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Valvular Heart Disease

Keywords

etomidate; cortisol level; inotrope; cardiac patients

Outcome Measures

Primary Outcomes (1)

• 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).

  baseline (before induction), 2, 4, 8, and 24 hrs

Secondary Outcomes (2)

• the use of inotropes for maintaining hemodynamic

  24 hours

• Length of ICU and hospital stay

  30 days

Study Arms (2)

etomidate

ACTIVE COMPARATOR

Drug: etomidate

thiopentone

ACTIVE COMPARATOR

Drug: thiopentone

Interventions

etomidate DRUG

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.

Also known as: Etomidate Lipuro (B Braun company)

etomidate

thiopentone DRUG

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

Also known as: Anesthal (Jagsonpal pharmaceuticals Ltd)

thiopentone

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year or older cardiac patient undergoing cardiac surgery (CABG or valve surgery) with the use of cardiopulmonary bypass -

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital Mahidol University

Bangkok, 10700, Thailand

Location

Related Publications (1)

• 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.

  PMID: 26437535 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases

Interventions

Etomidate; Thiopental

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiobarbiturates; Barbiturates; Pyrimidinones; Pyrimidines

Study Officials

• Manee Raksakietisak, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 20, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 23, 2014

Record last verified: 2014-05

Locations

TH (1)