Comparison of the effect of Ketofol (combination of Ketamin and Propofol) with Propofol during anesthesia induction on hemodynamic changes in patients undergo laparotomy
Objectives:
Blood pressure and heart rate changes during anesthesia induction with intravenous anesthetic agents are common complications in laparotomy. The aim of this study is to prevent these complications with the usage of a combined drug (Propofol and Ketamin).
Design:
In this clinical trial 90 patients who are candidate for laparotomy under general anesthesia will be randomly divided into two groups; the control group and the trial group (each group has 45 members). Age, sex and other patients' information such as type of the surgeries and past medical histories will be documented.
Setting and conduct:
The patients in the trial group will receive Ketofol (combination of Ketamin and Propofol) for general anesthesia induction and the patients in the control group will receive just Propofol for anesthesia induction. The intubation method is the same in the patients of both groups.
Major inclusion and exclusion criteria:
Patients who are candidate for laparotomy under general anesthesia with ASA class 1 in NPO condition, with neither urgent circumstances nor underline diseases.
Intervention:
Receiving Ketofol or Propofol intravenously.
Main outcome measures (variables):
Mean heart rate, systolic blood pressure and diastolic blood pressure will be assessed in 4 times before and after anesthesia induction and be compared with each other in the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021819037N6
Registration date:2015-03-05, 1393/12/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-05, 1393/12/14
Registrant information
Name
Mahdieh Yousef-Zanjani
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6004
Email address
yusefi.mahdieh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-09-16, 1393/06/25
Expected recruitment end date
2015-03-16, 1393/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Ketofol (combination of Ketamin and Propofol) with Propofol during anesthesia induction on hemodynamic changes in patients undergo laparotomy
Public title
Comparison of the effect of Ketofol with Propofol on patients' vital sign changes during laparotomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 20 to 60 years of age who are candidate for laparotomy (including appendectomy, gastrectomy, cholecystectomy and other kinds of laparotomy) under general anesthesia and are in ASA class 1 (The American Society of Anesthesiologists Physical Status classification system): Normal healthy patients with no organic, physiologic, or psychiatric disturbance.
Exclusion criteria:
Patients who use cardiac or anti-hypertensive or analgesic or sedative agents, patients who are not NPO (nil per os), diabetic or pregnant patients.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study the candidate patients for laparotomy will be randomly divided into one of the groups (trial or control) by usage of colored carts.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Boulevard
City
Qazvin
Postal code
Approval date
2014-07-14, 1393/04/23
Ethics committee reference number
28.20.8950
Health conditions studied
1
Description of health condition studied
Heart rate instability due to anesthesia
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Blood pressure instability due to anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mean heart rate
Timepoint
In 4 times: before induction, 3, 5 and 10 minutes after induction
Method of measurement
The monitor device
2
Description
Mean systolic pressure
Timepoint
In 4 times: before induction, 3, 5 and 10 minutes after induction
Method of measurement
The monitor device
3
Description
Mean diastolic pressure
Timepoint
In 4 times: before induction, 3, 5 and 10 minutes after induction
Method of measurement
The monitor device
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group (trial):
Receiving handmade drug, Ketofol: 10 ml Propofol solution (10 mg/ml, from Fresenius Kabi drug manufacturing company, Germany) with 10 ml Ketamin solution (50 mg/ml, from Rotxmedica drug manufacturing company, Germany). One dose of the combined solution was admitted for the patients intravenously for anesthesia induction (1.5 mg/kg).
Category
Other
2
Description
Second intervention group (control):
Receiving Propofol solution (10 mg/ml, from Fresenius Kabi drug manufacturing company, Germany). One dose of this drug was admitted for the patients intravenously for anesthesia induction (1.5 mg/kg).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat General Hospital
Full name of responsible person
Dr. Hamid Kayalha
Street address
Taavon Square
City
Qazvin
2
Recruitment center
Name of recruitment center
Shahid Rajayi Hospital
Full name of responsible person
Dr. Hamid Kayalha
Street address
Taavon Square
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Dr. Mohammad Kolahdouzha
Street address
Velayat Hospital, Taavon Square
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hamid Kayalha
Position
Professor, Anesthesiologist
Other areas of specialty/work
Street address
Shahid Bahonar Boulevard
City
Qazvin
Postal code
Phone
+98 28 3333 6004
Fax
Email
mohammad.kolahdouzha2050@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Velayat General Hospital
Full name of responsible person
Dr. Mohammad Kolahdouzha
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Taavon Square
City
Qazvin
Postal code
Phone
+98 28 3379 0620
Fax
Email
mohammad.kolahdouzha2050@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)