Objectives: the aim of this study is to compare the effect of propofol and ketofol (ketamine-propofol mixture) on EA in children .
Design: randomized clinical trial
Setting and conduct: in this study, 87 ASA (American Society of Anesthesiologist) class I and II, candidate for elective tonsillectomy in Valiasr hospital of zanjan, will divide into two groups.Inclusion criteria are: age between 3-12 years old; ASA class I and II and elective tonsillectomy. Exclusion criteria are: increased intracranial or intraocular pressure; porphyria; hepatic dysfunction; allergy to eggs or soybeans; history of psychiatric disorder; upper respiratory tract infection.
Intervention: control group, n=44, will receive infusion of propofol 100µg/kg/min and intervention group, n= 43 will receive infusion of ketamine 25µg/kg/min + propofol 75µg/kg/min.
At the end of surgery and after transmission to recovery room,on arrival time and after 10 and 30 min stay in recovery, gitation score will evaluated by Pediatric Anesthesia Delirium Emergence (PAED).
Main outcome measure is postanesthesia agitation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082829414N3
Registration date:2017-10-29, 1396/08/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-29, 1396/08/07
Registrant information
Name
Vahideh Rashtchi
Name of organization / entity
Zanjan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 341 1683
Email address
rashtchi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zanjan University of Medical Sciences, Dr Alireza Shogli
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effects of Propofol and Ketofol (Ketamine-Propofol mixture) on Emergence Agitation in Children undergoing Tonsillectomy
Public title
Effects of Propofol and Ketofol (Ketamine-Propofol mixture) on Emergence Agitation in Children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria are: age between 3-12 years old; ASA class I and II and elective tonsillectomy. Exclusion criteria are: increased intracranial or intraocular pressure; porphyria; hepatic dysfunction; allergy to eggs or soybeans; history of psychiatric disorder; upper respiratory tract infection.
Age
From 3 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
87
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
Ethics Committee of Zanjan univercity of medical sciences
Street address
Zanjan University of Medical Sciences, Azadi Avenue
City
Zanjan
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
IR.ZUMS.REC.1393.70
Health conditions studied
1
Description of health condition studied
postanesthesia agitation
ICD-10 code
XXI
ICD-10 code description
Factors influencing health status and contact with health services
Primary outcomes
1
Description
Postanesthesia agitation
Timepoint
On arrival and after 10 and 30 min stay in recovery
Method of measurement
Pediatric Anesthesia Emergence Delirium
Secondary outcomes
1
Description
Laryngospasm
Timepoint
First 30 min in recovery
Method of measurement
By anesthesiologist
2
Description
Bronchospasm
Timepoint
First 30 min in recovery
Method of measurement
By anesthesiologist
3
Description
Patients requiring sedative
Timepoint
First 30 min in recovery
Method of measurement
By anesthesiologist
4
Description
Bleeding
Timepoint
First 30 min in recovery
Method of measurement
By anesthesiologist
Intervention groups
1
Description
Group p, control group, n=44, infusion of propofol 100µg/kg/min
Category
Treatment - Drugs
2
Description
Group k or ketofol , intervention group, n= 43:infusion of ketamine 25µg/kg/min + propofol 75µg/kg/min
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr. Ali Esmaeli
Street address
Valiasr Hospital, Fazlolah noori avenue
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zanjan University of Medical Sciences
Full name of responsible person
Dr Alireza Shogli
Street address
Zanjan University of Medical Sciences, Azadi avenue
City
Zanjan
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, Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Ali Esmaeli
Position
Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr St.
City
Zanjan
Postal code
Phone
+98 24 3302 3270
Fax
Email
ALI.ESMAEILI26@YAHOO.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Ali Smaelie
Position
Anistesthesiolog
Other areas of specialty/work
Street address
Valiasr Hospital
City
Zanjan
Postal code
Phone
+98 24 3302 3270
Fax
Email
ALI.ESMAEILI26@YAHOO.COM
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Vahideh Rashtchi
Position
Anesthesioligist
Other areas of specialty/work
Street address
Musavi Hospital, Gavazang Avenue
City
Zanjan
Postal code
Phone
+98 24 3302 3270
Fax
Email
vrashtchi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)