The objective of the present study is to compare hemodynamic changes between propofol– remifentanil and isoflurane anesthesia for repair of cleft palate in infants. A total of 126 infants, aged 4–24 months, ASA class I or II, candidates for surgery of cleft palate repair, will be prospectively enrolled in the study. After preoperative examination infants will be randomized to one of the two groups to receive either a propofol–remifentanil or a isoflurane anesthesia. Group 1 will receive propofol (100-150mcg/kg/min) and remifentanil (0.2-0.5mcg/kg) as the maintenance. Group 2 will receive isoflurane (1.2%-1.5%). Both groups will receive oxygen/nitrous oxide 50%/50% for maintenance of anesthesia. Bispectral index (BIS) will be used after induction of anesthesia. The level of anesthesia will be maintained at 50±10 limit. Morphine (0.1mg/kg) will be administered 15-30 minute before termination of the surgery in group 1. Heart rate, arterial blood pressure, fentanyl dosage, endtidal concentrations of O2, and CO2 will be recorded every10 min from the beginning of the surgery until the end of anesthesia and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103106022N1
Registration date:2011-05-07, 1390/02/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-05-07, 1390/02/17
Registrant information
Name
Reza Taheri
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1526 2250
Email address
taherireza@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hemodynamic changes between propofol–remifentanil and isoflurane anesthesia for repair of cleft palate in infants
Public title
Comparison of hemodynamic changes between propofol–remifentanil and isoflurane anesthesia for repair
of cleft palate in infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 4-24 months, ASA class I or II, undergoing cleft palate surgery
Exclusion criteria: predisposition for malignant hyperthermia, cerebral disease, history of apnea, any syndromic disorder
Age
To 2 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Ave,
City
Tabriz
Postal code
Approval date
2010-10-07, 1389/07/15
Ethics committee reference number
5/4/5149
Health conditions studied
1
Description of health condition studied
Anesthesia
ICD-10 code
Y48.0
ICD-10 code description
Anaesthetics and therapeutic gases
Primary outcomes
1
Description
Hemodinamic differences
Timepoint
every 10 minutes during anesthesia
Method of measurement
electrocardiogram and blood pressure measurment for evaluation of heart rate and blood pressure
Secondary outcomes
1
Description
pain and agitation
Timepoint
every 10 minutes during anesthesia
Method of measurement
Flacc score
Intervention groups
1
Description
Intervention group will receive remifentnil (0.2-0.5mcg/kg/min) and propofol (100-150mcg/kg/min), during 4-5 hours anesthesia
Category
Treatment - Drugs
2
Description
Control group will receive 1.2-1.5% MAC isoflurane through the ventilator, during 4 hours anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children hospital of Tabriz
Full name of responsible person
Reza Taheri
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Ostad Rahimi
Street address
Tabriz University of Medical Sciences, Tabriz
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
Children hospital of Tabriz
Full name of responsible person
Reza Taheri
Position
Anesthesiologist
Other areas of specialty/work
Street address
Children hospital of Tabriz, Sheshgelan Avenue,Tabriz
City
Tabriz
Postal code
Phone
+98 914 102 4249
Fax
Email
dr.reza.taheri@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Children hospital of Tabriz
Full name of responsible person
Reza Taheri
Position
Anesthesiologist
Other areas of specialty/work
Street address
Children hospital of Tabriz, Sheshgelan Avenue, Tabriz,
City
Tabriz
Postal code
Phone
+98 914 102 4249
Fax
Email
dr.reza.taheri@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Reza Taheri
Position
Other areas of specialty/work
Street address
City
Tabriz
Postal code
Phone
Fax
Email
dr.reza.taheri@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)