Single Dose of Etomidate and Adrenal Cortex

NCT01792037 | Completed Phase 4 DMC

• 1 other identifier: 26177
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Adrenocortical Deficiency; Hemodynamic Instability

Outcome Measures

Primary Outcomes (1)

• effect of use of steroid on adrenal cortex prior to single dose etomidate by comparing cortisol levels

  24 hours

Secondary Outcomes (1)

• compare effects of midazolam and etomidate on systemic blood pressure

  24 hours

Study Arms (3)

Etomidate

ACTIVE COMPARATOR

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

etomidate, steroid

ACTIVE COMPARATOR

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; Drug: methylprednisolone

midazolam

ACTIVE COMPARATOR

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

Interventions

Etomidate DRUG

Also known as: etomidate lipuro, BRAUN

Etomidate; etomidate, steroid

Midazolam DRUG

Also known as: Dormicum,Roche

midazolam

methylprednisolone DRUG

Also known as: Prednol-L, Mustafa Nevzat

etomidate, steroid

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department

Istanbul, Fatih, 34400, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 20828877 BACKGROUND

MeSH Terms

Interventions

Etomidate; Midazolam; Methylprednisolone

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Fatis Altindas, Prof.

  Chairman of the Department of Anesthesiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: February 15, 2013
• Study Start: December 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 26, 2013

Record last verified: 2013-02

Locations

TU (1)