Single Dose of Etomidate and Adrenal Cortex

Phase 4

Completed

• Conditions: Adrenocortical Deficiency; Hemodynamic Instability
• Interventions: Drug: Etomidate; Drug: Midazolam; Drug: methylprednisolone

• Registration Number: NCT01792037
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Status Verified: 2013-02
• Study First Submitted: 2013-02-12
• Study First Submitted QC: 2013-02-14
• Study First Posted: 2013-02-15
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Etomidate	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.
etomidate, steroid	Etomidate	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.
midazolam	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.
etomidate, steroid	methylprednisolone	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.

Primary Outcome Measures

Name	Time	Method
effect of use of steroid on adrenal cortex prior to single dose etomidate by comparing cortisol levels	24 hours

Secondary Outcome Measures

Name	Time	Method
compare effects of midazolam and etomidate on systemic blood pressure	24 hours

Trial Locations

Locations (1)

Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department; 🇹🇷 Istanbul, Fatih, Turkey