The aim of this randomized double-blind clinical trial is to evaluate and comparison the hemodynamic changes of propofol + ketamine and etomidate during anesthesia induction. A total of 80 patients, meeting eligibility criteria, were randomly allocated into two equal groups. Inclusion criteria are First time elective CABG surgery; Age between 40 and 70 years; EF<40%. Exclusion criteria are 70 >MAP>110 mmHg; CABG with valve operation; Received etomidate or propofol or thiopental in one week ago; Egg and soy allergy; Sensitivity to etomidate or propofol or ketamine; Adrenal insufficiency. After establishing arterial line and routine monitors, blood pressure (systole, diastole and mean arterial pressure) and heart rate are measured and serve as baseline values. At first, all patients will receive 0.02 mg/kg midazolam and 2 µg/kg fentanyl. One minute later in control group Normal saline + 0.2 mg/kg Etomidate and in intervention group 1 mg/kg Ketamine + 1.5 mg/kg Propofol will be infused. Immediately after the prescribed hypnotic drug, 0.2 mg/kg cisatracurium for muscle relaxation and ease of intubation will be used. 1 min after administration of hypnotic drugs just before laryngoscopy as well as 1, 2 and 3 min after laryngoscopy and tracheal intubation, blood pressure and heart rate will be measured and compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207184365N14
Registration date:2012-11-07, 1391/08/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-07, 1391/08/17
Registrant information
Name
Afshin Gholipour Baradari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 1245
Email address
gholipourafshin@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mazandaran University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Hemodynamic parameters of two regimens propofol-ketamin & etomidate during anesthesia induction in low EF CABG patients
Public title
Comparison of the Hemodynamic parameters of two regimens propofol-ketamin & etomidate during anesthesia induction in low EF CABG patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: First time elective CABG surgery; Age between 40 and 70 years; EF<40%
Exclusion criteria:70 >MAP>110 mmHg; CABG with valve operation; Received etomidate or propofol or thiopental in one week ago; Egg and soy allergy; Sensitivity to etomidate or propofol or ketamine; Adrenal insufficiency
Age
From 40 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Postal code
46175866
Approval date
2012-09-15, 1391/06/25
Ethics committee reference number
91-105
Health conditions studied
1
Description of health condition studied
Hemodynamic Change
ICD-10 code
197.9
ICD-10 code description
Postprocedural disorder of circulatory system, unspecified
Primary outcomes
1
Description
Mean arterial pressure
Timepoint
Before laryngoscopy as well as immediately, 1, 2 and 3 min after tracheal intubation
Method of measurement
Invasive Blood Pressure
2
Description
Systolic blood pressure
Timepoint
Before laryngoscopy as well as immediately, 1, 2 and 3 min after tracheal intubation
Method of measurement
Invasive Blood Pressure
3
Description
Diastolic blood pressure
Timepoint
Before laryngoscopy as well as immediately, 1, 2 and 3 min after tracheal intubation
Method of measurement
Invasive Blood Pressure
4
Description
Heart rate
Timepoint
Before laryngoscopy as well as immediately, 1, 2 and 3 min after tracheal intubation
Method of measurement
Heart monitoring
Secondary outcomes
1
Description
Muscle twitching
Timepoint
After anesthetic infusion
Method of measurement
Inspection
2
Description
pain on injection
Timepoint
After anesthetic infusion
Method of measurement
Inspection
Intervention groups
1
Description
Control group: Normal saline + 0.2 mg/kg Etomidate