Completed
the Effect of Single Dose of Etomidate Used During Emergency Intubation on Hemodynamics and Adrenal Cortex: a Randomized Clinical Trial
What is being tested
Etomidate
+ Etomidate
+ methylprednisolone
Drug
Who is being recruted
From 25 to 65 Years
+2 Eligibility Criteria
How is the trial designed
Prevention Study
Phase 4
Interventional
Study Start: December 2012
Summary
Principal SponsorIstanbul University
Last updated: August 26, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorIstanbul University
Last updated: August 26, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
90 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 25 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
1 inclusion criteria required to participate
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
1 exclusion criteria prevent from participating
Patients using steroid prior to the intubation and/or patients with chronical inflammatory diseases will be excluded from the study
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorAfter 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 II
Active ComparatorAfter 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 III
Active ComparatorAfter 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.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
Istanbul, Turkey (Türkiye)Open Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department in Google MapsCompletedOne Study Center