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Single Dose of Etomidate and Adrenal Cortex

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ClinicalTrials.gov Identifier: NCT01792037
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : August 26, 2013
Sponsor:
Information provided by (Responsible Party):
Guniz M.Koksal, Istanbul University

Brief Summary:
we aim to evaluate the effects of single dose of etomidate or use of steroid prior to etomidate during emergency intubation on hemodynamics and adrenal cortex.

Condition or disease Intervention/treatment Phase
Adrenocortical Deficiency Hemodynamic Instability Drug: Etomidate Drug: Midazolam Drug: methylprednisolone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: the Effect of Single Dose of Etomidate Used During Emergency Intubation on Hemodynamics and Adrenal Cortex: a Randomized Clinical Trial
Study Start Date : December 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Etomidate
After taking of the blood samples, patients in Group I will be intubated with 0.3 mg/kg etomidate iv. Blood samples will be repeated in the 4th and 24th hour of the intubation.systolic, diastolic and mean arterial pressures, heart rates will be recorded with 15 minutes intervals in the first hour and after that hourly during surgery.Cortisol Levels in the 0,4th and 24th hour will be compared from the blood samples acquired.
Drug: Etomidate
Other Name: etomidate lipuro, BRAUN

Active Comparator: etomidate, steroid
After taking of the blood samples, patients in Group II will be intubated with 0.3 mg/kg etomidate iv following a 2mg/kg methylprednisolone iv Blood samples will be repeated in the 4th and 24th hour of the intubation.systolic, diastolic and mean arterial pressures, heart rates will be recorded with 15 minutes intervals in the first hour and after that hourly during surgery.Cortisol Levels in the 0,4th and 24th hour will be compared from the blood samples acquired.
Drug: Etomidate
Other Name: etomidate lipuro, BRAUN

Drug: methylprednisolone
Other Name: Prednol-L, Mustafa Nevzat

Active Comparator: midazolam

After taking of the blood samples, patients in Group III will be intubated with 0.01 mg/kg midazolam iv. Blood samples will be repeated in the 4th and 24th hour of the intubation.systolic, diastolic and mean arterial pressures, heart rates will be recorded with 15 minutes intervals in the first hour and after that hourly during surgery.

Cortisol Levels in the 0,4th and 24th hour will be compared from the blood samples acquired.

Drug: Midazolam
Other Name: Dormicum,Roche




Primary Outcome Measures :
  1. effect of use of steroid on adrenal cortex prior to single dose etomidate by comparing cortisol levels [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. compare effects of midazolam and etomidate on systemic blood pressure [ Time Frame: 24 hours ]


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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between 25-65 years old with American Society of Anesthesiology scores III or IV that have applied to emergency department and receives an indication for intubation by the intensive care unit physicians will be included to the study

Exclusion Criteria:

  • Patients using steroid prior to the intubation and/or patients with chronical inflammatory diseases will be excluded from the study.

Information from the National Library of Medicine

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): NCT01792037


Locations
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Turkey
Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
Istanbul, Fatih, Turkey, 34400
Sponsors and Collaborators
Istanbul University
Investigators
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Study Director: Fatis Altindas, Prof. Chairman of the Department of Anesthesiology

Publications:
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Responsible Party: Guniz M.Koksal, Assoc.Prof., Istanbul University
ClinicalTrials.gov Identifier: NCT01792037    
Other Study ID Numbers: 26177
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Midazolam
Etomidate
Prednisolone hemisuccinate
Prednisolone phosphate
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones