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Single Dose of Etomidate and Adrenal Cortex

NCT ID: NCT01792037

Last Updated: 2013-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adrenocortical Deficiency Hemodynamic Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Etomidate

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Etomidate

Intervention Type DRUG

methylprednisolone

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Interventions

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Etomidate

Intervention Type DRUG

Midazolam

Intervention Type DRUG

methylprednisolone

Intervention Type DRUG

Other Intervention Names

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etomidate lipuro, BRAUN Dormicum,Roche Prednol-L, Mustafa Nevzat

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Guniz M.Koksal

Assoc.Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatis Altindas, Prof.

Role: STUDY_DIRECTOR

Chairman of the Department of Anesthesiology

Locations

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Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department

Istanbul, Fatih, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Tekwani KL, Watts HF, Sweis RT, Rzechula KH, Kulstad EB. A comparison of the effects of etomidate and midazolam on hospital length of stay in patients with suspected sepsis: a prospective, randomized study. Ann Emerg Med. 2010 Nov;56(5):481-9. doi: 10.1016/j.annemergmed.2010.05.034. Epub 2010 Sep 15.

Reference Type BACKGROUND
PMID: 20828877 (View on PubMed)

Other Identifiers

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26177

Identifier Type: -

Identifier Source: org_study_id