Comparison of the effect of propofol plus ketamine with propofol plus etomidate on hemodynamic stability during induction of anesthesia in elderly patients candidate for elective surgeries
Our aim in this study is to compare the effect of propofol plus ketamine with propofol plus etomidate on hemodynamic stability during induction of anesthesia in elderly patients candidate for elective surgeries. Key inclusion criteria are to have indication for elective surgeries and to be 50 or over 50 years old. Key exclusion criteria are pregnancy and to have contraindication for etomidate, ketamine and propofol. 60 eligible males and females candidate for surgery in Emam Reza hospital, Tabriz would be studied in two groups of 30. In the group Ketofol, ketamine 0.75 mg/kg and propofol 1 mg/kg would be administered intra-venously to induct the anesthesia. In addition, Ketamine 0.25 mg/kg and propofol 1 mg/kg would be prepared to be administered as a second dose in case of patient agitation. In the group Etofol, etomidate 0.2 mg/kg and propofol 1 mg/kg will be administered intra-venously to induct the anesthesia. In addition, Etomidate 0.1 mg/kg and propofol 1 mg/kg would be prepared to be administered as a second dose in case of patient agitation. Systolic and diastolic blood pressure, mean arterial blood pressure, heart rate and blood O2 saturation would be measured before and immediately after induction, 1 and 3 minutes after intubation. And then, the results would be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112224731N10
Registration date:2012-01-01, 1390/10/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-01-01, 1390/10/11
Registrant information
Name
Hamze Hosseinzade
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 7055
Email address
hosseinz@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2012-04-19, 1391/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of propofol plus ketamine with propofol plus etomidate on hemodynamic stability during induction of anesthesia in elderly patients candidate for elective surgeries
Public title
propofol with ketamine or propofol with etomidate, which one influences the hemodynamic stability lesser?
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: to have indication for elective surgeries; to be 50 or over 50 years old. Exclusion criteria: to have indication for emergency surgery; addiction to opiate; pregnancy; patients being treated with sedative or antipsychotic drugs in the past month; to have a personality disorder; to have body weight more than 20% of the ideal body weight for that height and gender; to have contraindication for etomidate, ketamine and propofol
Age
From 50 years old to 149 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
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
Ethics committee of Tabriz University of Medical Sciences
Street address
Daneshgah square
City
Tabriz
Postal code
Approval date
2011-07-25, 1390/05/03
Ethics committee reference number
9059
Health conditions studied
1
Description of health condition studied
Change in heart rate caused by anesthesia induction
ICD-10 code
R00.1
ICD-10 code description
Bradycardia, unspecified
2
Description of health condition studied
Change in blood pressure caused by anesthesia induction
ICD-10 code
I95.9
ICD-10 code description
Hypotension, unspecified
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
Before and immediately after induction, 1 and 3 minutes after intubation
Method of measurement
Non-invasive monitoring device with automatic cuff
2
Description
Heart rate
Timepoint
before and immediately after induction, 1 and 3 minutes after intubation
Method of measurement
Continuous ECG monitoring
3
Description
Blood O2 saturation
Timepoint
before and immediately after induction, 1 and 3 minutes after intubation
Method of measurement
pulse oximetry
4
Description
Diastolic blood pressure
Timepoint
before and immediately after induction, 1 and 3 minutes after intubation
Method of measurement
Non-invasive monitoring device with automatic cuff
5
Description
Mean arterial blood pressure
Timepoint
before and immediately after induction, 1 and 3 minutes after intubation
Method of measurement
non-invasive monitoring devices with automatic cuff
Secondary outcomes
empty
Intervention groups
1
Description
In the group Ketofol, ketamine 0.75 mg/kg and propofol 1 mg/kg would be administered intra-venously to induct the anesthesia. Plus, Ketamine 0.25 mg/kg and propofol 1 mg/kg would be prepared to be administered as a second dose in case of patient agitation.
Category
Prevention
2
Description
In the group Etofol, etomidate 0.2 mg/kg and propofol 1 mg/kg will be administered intra-venously to induct the anesthesia. Plus, Etomidate 0.1 mg/kg and propofol 1 mg/kg would be prepared to be administered as a second dose in case of patient agitation.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Hamzeh Hosseinzadeh
Street address
Emam Reza hospital, Golgasht street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamzeh Hosseinzadeh
Street address
Emam Reza hospital, Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mahmoud Vasebi
Position
Anesthesiology resident, student
Other areas of specialty/work
Street address
Emam Reza hospital, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 1335 7314
Fax
Email
vasebim@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahmoud Vasebi
Position
Anesthesiology resident, student
Other areas of specialty/work
Street address
Emam Reza hospital, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 1335 7314
Fax
Email
vasebim@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahmoud Vasebi
Position
Anesthesiology resident, student
Other areas of specialty/work
Street address
Emam Reza hospital, Golgasht street
City
Tabriz
Postal code
Phone
Fax
Email
vasebim@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)