Etomidate is the only hypnotic drug that when injected for induction of aneasthesia and laryngoscopy has minimal or no effect on hemodynamic. Despite this great advantage , etomidate
Has suppressing effect on producing steroids from adrenal gland. Adrenal suppression can be dangerous in septic and critically ill patients and can cause increase in mortality and morbidity in these patients.
In this study we will combine two kind of drugs for induction of aneasthesia one with excitatory effect (ketamine) and one with inhibitory effect (Nesdonal) on cardiovascular system; and compare their effect on hemodynamic vs etomidate . 100 patients randomly will separate in two groups of 50. Systolic, diastolic and mean arterial pressure and heart rate before induction as baseline, one minute after inducton and before,1,2&3 minute after laryngoscopy will be measure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309242883N4
Registration date:2014-01-08, 1392/10/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-08, 1392/10/18
Registrant information
Name
Mohammadreza Habibi
Name of organization / entity
Mazandarn University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 15 1222 3023
Email address
mhabibi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran Uiversity of Medical Sciences and Health Services Deputy of Research
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Hemodynamic Changes of two regimens thiopental Na - ketamin & etomidate during anesthesia induction in low EF CABG patients
Public title
Effect of ketamin- nesdonal combination in induction of aneasthesia in CABG patiant with low ejection fraction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:1- Elective surgery
2-Age range 40 to 70
3-EF low than 50%
Exclusion criteria:1- Adrenal insuficiency
2-Intake of etomidate or nesdonal in one week
3-Corton intake in six mounth
4-sensitivity to etomidate or nesdonal
5-sepsis, endocaditis, chronic inflamatory disaeses
6-sever norologic or psychiatric diseases
7-any other operation with CABG
8-CABG with great vessel operation (et.bental)
9-dificult intubation(laryngoscopy more than 30 secend)
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Mazandaran University of Medical Sciences
Street address
serah Jouibar, Valiasr Ave.
City
Sari
Postal code
Approval date
2012-02-14, 1390/11/25
Ethics committee reference number
1496
Health conditions studied
1
Description of health condition studied
Atherosclerotic cardiovascular disease
ICD-10 code
I25.0
ICD-10 code description
Atherosclerotic cardiovascular disease
Primary outcomes
1
Description
systolic blood pressure
Timepoint
before aneasthesia, one minute after injection of hypnotic, one minute before,1,2&3 minute after laryngoscopy
Method of measurement
Invasive bloob pressure monitor
2
Description
diastolic blood pressure
Timepoint
before aneasthesia, one minute after injection of hypnotic, one minute before,1,2&3 minute after laryngoscopy
Method of measurement
Invasive bloob pressure monitor
3
Description
mean arterial blood pressure
Timepoint
before aneasthesia, one minute after injection of hypnotic, one minute before,1,2&3 minute after laryngoscopy
Method of measurement
Invasive bloob pressure monitor
Secondary outcomes
1
Description
heart rate per minute
Timepoint
before aneasthesia, one minute after injection of hypnotic, one minute before,1,2&3 minute after laryngoscopy
Method of measurement
manitor
Intervention groups
1
Description
Control group: Induction of aneasthesia with etomidate 0.2 mg/kg
Category
Treatment - Other
2
Description
Intervention group: Induction of aneasthesia with nesdonal 3mg/kg+ ketamin 1mg/kg
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemezahra Hospital
Full name of responsible person
Dr. Mohammadreza Habib
Street address
Artesh Blv.
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran Uiversity of Medical Sciences and Health Services
Full name of responsible person
Ahmad Ali Enayati
Street address
Deputy of Research, Moalem sq
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran Uiversity of Medical Sciences and Health Services
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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Habibi
Position
Assistant Professor; Fellowship of Cadiac Anesthesia
Other areas of specialty/work
Street address
Mazandaran Heart Center; fattemeh alzahra Hos. Sari
City
SARI
Postal code
Phone
+98 15 1222 3023
Fax
+98 15 1222 4002
Email
mohammadreza.habibi@gmail.com
Web page address
www.mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Habibi
Position
Assistant Professor; Fellowship of Cadiac Anesthesia
Other areas of specialty/work
Street address
Mazandaran Heart Center; fattemeh alzahra Hos.
City
Sari
Postal code
Phone
+98 15 1222 3023
Fax
+98 15 1222 4002
Email
mohammadreza.habibi@gmail.com
Web page address
www.mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Habibi
Position
Assistant Professor; Fellowship of Cadiac Anesthesia
Other areas of specialty/work
Street address
Mazandaran Heart Center; fattemeh alzahra Hos.
City
Sari
Postal code
Phone
+98 15 1222 3023
Fax
Email
mohammareza.habibi@gmail.com
Web page address
www.mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)