Comparison of anesthesia method with combined ketamine / sevoflurane and combined propofol/ketamine and its efficacy on blood pressure and heart rate changes in patients with diagnostic angiography
The purpose of this study is Comparison of anesthesia method with combined ketamine / sevoflurane and combined propofol/ketamine and its efficacy on blood pressure and heart rate changes in patients with diagnostic angiography. Patients aged 2 to 8 years, ASA I, II without metabolic, kidney and liver disease will be studied. 60patient refferd to Sina Hospital Tehran divided into 2 groups. in first group, induction of anesthesia will performed with ketamine and will maintained with sevoflurane and the Laryngeal mask airway. In the second group, induction and maintaine of anesthesia will performed with mixed propofol / ketamine and Laryngeal mask airway. in each group, heart rate, respiratory rate and artrial blood pressure will be checked and The 2 groups will be compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015013012642N12
Registration date:2015-02-27, 1393/12/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-02-27, 1393/12/08
Registrant information
Name
Majid Golestani Eraghi
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3336 0547
Email address
dr.golestani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Tehran University of Medical Sciences
Expected recruitment start date
2015-03-01, 1393/12/10
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of anesthesia method with combined ketamine / sevoflurane and combined propofol/ketamine and its efficacy on blood pressure and heart rate changes in patients with diagnostic angiography
Public title
The effect of anesthetic drugs on blood pressure and heart rate changes in patients with diagnostic angiography
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: ASA I,II, Children 2 to 8 years, Written consent from the parent
exclusion criteria: patients with pulmonary, hepatic, renal and metabolic disease, Patients with a prior history of cardiac and thoracic surgery, Patients who need more airway support and pulmonary care
Age
From 2 years old to 8 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Ghods Ave, Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2013-12-17, 1392/09/26
Ethics committee reference number
2172
Health conditions studied
1
Description of health condition studied
Effects of anesthetic drugs in diagnostic angiography
ICD-10 code
T88.7
ICD-10 code description
Unspecified adverse effect of drug or medicament
Primary outcomes
1
Description
Arterial oxygen pressure
Timepoint
Before and after induction of anesthesia
Method of measurement
artrial blood gaz analyzer device in mmHg
2
Description
Blood Pressure
Timepoint
Before and after induction of anesthesia
Method of measurement
Non-invasive barometer in mm Hg
Secondary outcomes
1
Description
Arterial pressure of carbon dioxide
Timepoint
Before and after induction of anesthesia.
Method of measurement
By the analyzer device in mmHg
2
Description
arterial pulmonary blood pressure
Timepoint
Before and after induction of anesthesia.
Method of measurement
by angiography in mmHg
Intervention groups
1
Description
in The first group, induction of anesthesia with intravenous injection ketamine with dose of one mg per killogeram and receive sevoflurane will started. After 3 minutes, Laryngeal mask airway will be inserted
Category
Prevention
2
Description
In the second group solution containing of 80 mg per liter ketamine / propofol and 0.1 mg per killogeram of the prepared solution was administered for induction of anesthesia then Anesthesia will performe with infusion of 0.01 mg per killogeram per minute of solution.Laryngeal mask will be inserted after 3 minutes
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Medical Center Hospital
Full name of responsible person
Majid Golestani Eraghi
Street address
Doctor Mohamed Gharib St, Keshavarz Boulevard
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Tehran University of Medical Sciences
Full name of responsible person
Masood Yoonesian
Street address
Central Organization of Tehran University of Medical Sciences, Ghods Ave, Keshavarz Boulvard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology of Tehran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Anesthesiology, Tehran University of Medical Sciences
Full name of responsible person
Behrang Nooralishahi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Keshavarz Boulevard, Doctor Mohamed Gharib St.
City
Tehran
Postal code
Phone
00
Fax
Email
b-nooralishahi@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Anesthesiology, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Golestani Eraghi
Position
Fellowship specialty anesthesia and intensive care
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad Ave
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
dr.golestani@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)