The effect of propofol and ketamine on the results of cerebral oximetry in children undergoing cardiac catheterization
Design
Clinical trial with two parallel groups, double-blind, randomized with flip the coin method, sample size of 44 patients
Settings and conduct
In Modares hospital cath. lab for all patients on awakening time, standard monitoring including pulse oximetry, electrocardiogram and NIBP as well as NIRS probe is connected and recorded. One group is given ketamine (1 mg per kg) for sedation with 0.1 mg per kg of midazolam and the other group is given propofol (1 mg per kg) with midazolam. Spo2, NIBP, NIRS findings are monitored and recorded upon awakening, immediately after induction and every 5 minutes thereafter
Participants/Inclusion and exclusion criteria
Children referring to the cath lab.of Shahid Modares Hospital for diagnostic cardiac catheterization
Intervention groups
Ketamine intervention group and propofol intervention group
Main outcome variables
Cerebral oximetry number by near infrared spectroscopy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180724040575N1
Registration date:2020-09-19, 1399/06/29
Registration timing:prospective
Last update:2020-09-19, 1399/06/29
Update count:0
Registration date
2020-09-19, 1399/06/29
Registrant information
Name
kamal fani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 4095
Email address
kamalfani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparative effect of propofol and ketamine sedation on cerebral oxymetry results in pediatric cardiac catheterisation
Public title
Comparison of the effect of propofol and ketamine on brain oximetry results
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children referring to the cath lab. of Shahid Modares Hospital for diagnostic cardiac catheterization
Exclusion criteria:
Parental dissatisfaction
Known allergy to ketamine or propofol
History of seizure or other neurological diseases
Age
From 6 months old to 60 months old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by flip the coin method. The allocation of two sides of a coin to each of the study groups was determined and then the number of coin samples was thrown and recorded
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and parents and the registrant of the research questionnaire (about used used medication) are blind. All parents have approved the consent form but are not aware of the grouping The anesthesiologist will prescribe a sedative based on the pre-determined group, but the person recording the questionnaire in the cath. lab. control room is not aware of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti University of Medical Sciences
Street address
Taleghani Hospital, velenjak, Tehran. Iran
City
Tehran
Province
Tehran
Postal code
19969111151
Approval date
2019-12-15, 1398/09/24
Ethics committee reference number
IR.SBMU.REC.1398.137
Health conditions studied
1
Description of health condition studied
Diagnostic cardiac catheterization in children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cerebral oximetry number by near infrared spectroscopy
Timepoint
Before and after catheterization every 5 minutes to the end of the procedure and transfer to the recovery room.
Method of measurement
Near infrared spectroscopy
Secondary outcomes
1
Description
heart beat
Timepoint
5 minutes
Method of measurement
By pulse oximetry and electrocardiogram monitoring device
2
Description
blood oxygen saturation
Timepoint
5 minutes
Method of measurement
By pulse oximetry device
3
Description
blood pressure
Timepoint
5 minutes
Method of measurement
by non-invasive sphygmomanometer
Intervention groups
1
Description
Intervention group: ketamine(As an anesthetic drug commonly used in sedation of children undergoing the procedure) is administered intravenously at doses of 1 mg per kg with control of vital signs and hemodynamics. The drug is repeated throughout the procedure based on the patient's reactions and the decision of the responsible anesthesiologist. Number of injections, total dose and duration of procedure and patient recovery time are recorded.Ketamine drug produced by Rotex Medica with an initial concentration of 50 mg / ml, which is diluted to 2 mg / ml is used.
Category
Treatment - Drugs
2
Description
Intervention group: propofol (As an anesthetic drug commonly used in sedation of children undergoing the procedure) is administered intravenously at doses of 1 mg per kg with control of vital signs and hemodynamics. The drug is repeated throughout the procedure based on the patient's reactions and the decision of the responsible anesthesiologist. Number of injections, total dose and duration of procedure and patient recovery time are recorded.Baxter 1% propofol is used, which is diluted up to 2 mg per milliter.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres Hospital
Full name of responsible person
Kamal Fani
Street address
Taleghani Hospital, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996911151
Phone
+98 21 2207 4089
Email
kamalfani@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Taleghani Hospital, Velenjak,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996911151
Phone
+98 21 2207 4089
Email
kamalfani@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kamal Fani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Modarres Hosp., Saadat abad Ave.,
City
Tehran
Province
Tehran
Postal code
19969111151
Phone
+98 21 2207 4095
Fax
Email
kamalfani@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kamal Fani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Modarres Hosp., Saadat abad Ave.,
City
Tehran
Province
Tehran
Postal code
19969111151
Phone
+98 21 2207 4095
Fax
Email
kamalfani@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kamal Fani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Modarres Hosp.,Saadat abad Ave.,
City
Tehran
Province
Tehran
Postal code
19969111151
Phone
+98 21 2207 4095
Fax
Email
kamalfani@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available