Comparison the effect of two drugs, propofol and fentanyl in controlling emergence agitation of 2 to10 years old children following general anesthesia with sevoflurane
Comparison the effect of propofol and fentanyl in controlling agitation following general anesthesia with sevoflurane
Design
A randomized, double-blind, clinical trial with a sample size of 50 patients
Settings and conduct
50 children aged 2 to 10 years old with class 1 or 2 American Society of Anesthesiologists (ASA) who candidate general anesthesia with sevoflurane in Kosar educational hospital of Sanandaj were evaluated. At the end of surgery , in the post anesthetic care unit (PACU), agitated patients was divided into two groups: one group received fentanyl and another group recieved propofol. Each patient was monitored for their complications and effects of treatment. In this study, participants, clinical caregivers, evaluator and therapist were blinded.
Participants/Inclusion and exclusion criteria
Children aged 2 to 10 years old with a grade 1 or 2 American Society of Anesthesiologists (ASA) under general anesthesia with sevoflurane were enrolled to the study, and children with a history of growth retardation, psychological or neurological illness ,abnormal or erritable airway were excluded from the study .
Intervention groups
Intervention group 1: propofol; Control group :fentanyl
Main outcome variables
Agitation score
nausea
vomiting
apnea
disturbance of consciousness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181130041804N1
Registration date:2019-01-23, 1397/11/03
Registration timing:registered_while_recruiting
Last update:2019-01-23, 1397/11/03
Update count:0
Registration date
2019-01-23, 1397/11/03
Registrant information
Name
Arash Amini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3356 5863
Email address
arash.amini@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-31, 1397/10/10
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of two drugs, propofol and fentanyl in controlling emergence agitation of 2 to10 years old children following general anesthesia with sevoflurane
Public title
Effect of two drugs, propofol and fentanyl in controlling emergence agitation following anesthesia with sevoflurane gas
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 2 to 10 years old
Class one or two of ASA
Children under general anesthesia with sevoflurane
Exclusion criteria:
Children with growth retardation
Children with psychological diseases
Children with neurological disease
Children with abnormal airway
Irritable children
Age
From 2 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The method of random allocation is permuted block randomization using following pattern.
Group A: Propophol drug
Group B: Fentanyl drug
BABA ABBA BBAA AABB BABA ABAB BAAB ABBA
In the first 4 patients, the first and third persons recieve fentanyl and the second and fourth patients recieve propofol.
In the next four, the first two recieve fentanyl drugs and the third and fourth patients recieve the drug propofol.
And so to the end of the of samples , the above pattern is used .
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant, the clinical caregiver and data analyser are not aware of the type of drug used, and only the researcher or the person other than above sofisticate the drug used (in an accidental manner) in an aluminum foil and give it to a clinical caregiver for injectin to the patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Kurdestan University of Medical Sciences
Street address
Pasdaran St, Kurdestan University of Medical Science
City
Sanandaj
Province
Kurdistan
Postal code
66614713446
Approval date
2018-10-20, 1397/07/28
Ethics committee reference number
IR.MUK.REC.1397.183
Health conditions studied
1
Description of health condition studied
agitation due to sevoflurane gas
ICD-10 code
XVIII
ICD-10 code description
Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified
Primary outcomes
1
Description
Agitation Score
Timepoint
5 ,10 ,15 ,20 minute after the treatment of Agitation
Method of measurement
RASS (Richmond agitation sedation scale)
Secondary outcomes
1
Description
Vomiting
Timepoint
5,10,15,20 minutes after injection of propofol or fentanyl
Method of measurement
In the form of positive or Negative by watching and reporting the caregiver
2
Description
Nausea
Timepoint
5,10,15,20 minutes after injection of propofol or fentanyl
Method of measurement
In the form of positive or Negative by watching and reporting the caregiver
Intervention groups
1
Description
Intervention Group: Receive 0.5mg/kg Propofol drug after agitation
Category
Treatment - Drugs
2
Description
Control Group: Recieve 0.5mcg/kg Fentanyl drug after agitation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational hospital of Kowsar, Sanandaj
Full name of responsible person
Dr Jamal Amjadi
Street address
Pasdaran Blvd، in front of Tamin Ejtemaii hospital
City
Sanandaj
Province
Kurdistan
Postal code
6617983476
Phone
+98 87 3361 1233
Email
kowsar@muk.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ebrahim Qaderi
Street address
Pasdaran Bulvd, Kurdestan University of Medical Science
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3182 7272
Email
info@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
I can send the fallowing upon request of the researchers:Participants data file, study protocol, clinical study report, the codes used in the analysis, data classification system
When the data will become available and for how long
One year after the print results
To whom data/document is available
Researchers in the University
Under which criteria data/document could be used
Without any condition
From where data/document is obtainable
Apply to my E.mail.adress
What processes are involved for a request to access data/document