Protocol summary

Summary
Etomidate and Propofol are common anesthetic agents. Previous studies say that Etomidate can be used in patients with limited hemodynamic reserve and Propofol can lead to more hemodynamic instabilities. This study was done to explore the cardiovascular response during the induction of anesthesia with Etomidate or, for comparison, Propofol in elective orthopedic surgeries. Methods: this study was a double blind randomized clinical trial study including patients 18-45 years of age that were admitted for elective orthopedic surgeries in 2012 and 2013.. Studied population are patients who will hospitalized for having elective orthopedic surgeries on their upper and lower extremities . Sampling will be done the convenience way and after the first patient is randomly allocated to one of the two groups, the rest of the patients will be alternately and in order of their admission to the hospital allocated to either the group of Propofol induced anesthesia or Etomidate induced anesthesia. 50 patients who has the inclusion criteria wiill be randomly divided into two groups of 25 patients. The first group undergo general anesthesia by Propofol and the second group is anesthetized by Etomidate Hemodynamic and cardiovascular indicators such as: SBP , DBP , MAP , HR , O2sat of patients will be measured and recorded before the induction of anesthesia, before intubation, and 1, 3, 5, and 10 minutes afterward . Finally all the gathered information will be recorded in a computer and wiill be analyzed using SPSS version 20.The Chi-square, T-student and repeated measures ANOVA test were used for data analysis. Inclusion criteria: being aged from 18 to 45 years old; having no underlying diseases; being of ASA 1 classification; being an applicant for elective orthopedic surgery on upper and lower extremities; not being allergic to anesthetic drugs; not having any expected problems of the airway; receiving no narcotics or sedative drugs before the anesthesia and not being hemodynamic instability before the anesthesia. Patients who were a 4 grade after the induction of anesthesia and laryngoscopy, or their laryngoscopy were lasted longer than 30 seconds, or were not anesthetized using the mentioned dose of drugs and received higher doses, were excluded from the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201304166617N2
Registration date: 2013-05-03, 1392/02/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-05-03, 1392/02/13
Registrant information
Name
Mehrdad Masoudifar
Name of organization / entity
Esfahan University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1268 2007
Email address
masoudifar@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2012-10-20, 1391/07/29
Expected recruitment end date
2013-07-21, 1392/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of cardiovascular response to the laryngoscopy and tracheal intubation after induction of anesthesia by propofol or etomidate
Public title
Comparison of cardiovascular response to the laryngoscopy and tracheal intubation after induction of anesthesia by propofol or etomidate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being aged from 18 to 45 years old; having no underlying diseases; being of ASA 1 classification; being an applicant for elective orthopedic surgery on upper and lower extremities; not being allergic to anesthetic drugs; not having any expected problems of the airway; receiving no narcotics or sedative drugs before the anesthesia and not being hemodynamic unstablility before the anesthesia. Patients who were a 4 grade after the induction of anesthesia and laryngoscopy, or their laryngoscopy were lasted longer than 30 seconds, or were not anesthetized using the mentioned dose of drugs and received higher doses, were excluded from the study.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezar Jarib st.
City
Isfahan
Postal code
Approval date
2011-11-09, 1390/08/18
Ethics committee reference number
22520

Health conditions studied

1

Description of health condition studied
General anesthesia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia

Primary outcomes

1

Description
Systolic blood pressure
Timepoint
Before intervention, at laryngoscopy time and 1 , 3 ,5 , 10 min after drug injection
Method of measurement
mm-hg, sphygmomanometer

2

Description
Diastolic bllod pressure
Timepoint
Before intervention, at laryngoscopy time and 1 , 3 ,5 , 10 min after drug injection
Method of measurement
mm-hg, sphygmomanometer

3

Description
Mean arterial pressure
Timepoint
Before intervention, at laryngoscopy time and 1 , 3 ,5 , 10 min after drug injection
Method of measurement
mm-hg, sphygmomanometer

4

Description
Heart rate
Timepoint
Before intervention, at laryngoscopy time and 1 , 3 ,5 , 10 min after drug injection
Method of measurement
ECG monitor

5

Description
O2 saturation
Timepoint
Before intervention, at laryngoscopy time and 1 , 3 ,5 , 10 min after drug injection
Method of measurement
Pulseoxymeter

Secondary outcomes

1

Description
Hypotension
Timepoint
Other complications of anaesthesia
Method of measurement
mm-Hg, sphygmomanometer

2

Description
Hypertension
Timepoint
Other complications of anaesthesia
Method of measurement
mm-Hg, sphygmomanometer

3

Description
Tachycardia
Timepoint
Other complications of anaesthesia
Method of measurement
ECG monitor

4

Description
Bradycardia
Timepoint
Before intervention, at laryngoscopy time and 1 , 3 ,5 , 10 min after drug injection
Method of measurement
ECG monitor

Intervention groups

1

Description
Propofol, 2.5 mg/kg within 30 seconds; IV.
Category
Treatment - Drugs

2

Description
Etomidate, 0.3 mg/kg within 30 seconds; IV.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital in Isfahan
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Taleb Azarm
Street address
Isfahan University of Medical Sciences, Hezar jarib St.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mehrdad Masoudifar
Position
Assistant professor
Other areas of specialty/work
Street address
Ayatollah Kashani hospital
City
Isfahan
Postal code
Phone
+98 31 1233 0091
Fax
Email
masoudifar@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mehrdad Masoudifar
Position
Assistant professor
Other areas of specialty/work
Street address
Isfahan university of medical sciences
City
Isfahan
Postal code
Phone
+98 31 1233 0091
Fax
Email
masoudifar@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mehrdad Masoudifar
Position
Assistant professor
Other areas of specialty/work
Street address
Ayatoallah Kashani hospital
City
isfahan
Postal code
Phone
Fax
Email
masoudifar@med.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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