Single Dose of Etomidate and Adrenal Cortex

Hemodynamic Instability Clinical Trial

Official title:

the Effect of Single Dose of Etomidate Used During Emergency Intubation on Hemodynamics and Adrenal Cortex: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792037
• Other study ID #: 26177
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2013
• Last updated: August 23, 2013
• Start date: December 2012
• Est. completion date: March 2013

Study information

• Verified date: February 2013
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adrenocortical Deficiency
• Hemodynamic Instability

Intervention

Drug:
• Etomidate

• Midazolam

• methylprednisolone

Locations

Country	Name	City	State
Turkey	Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect of use of steroid on adrenal cortex prior to single dose etomidate by comparing cortisol levels		24 hours	No
Secondary	compare effects of midazolam and etomidate on systemic blood pressure		24 hours	No