Comparison of the effect of isoflurane with propofol to reduce postoperative agitation for children under three years after probing surgery
Design
Clinical trial with control group, with parallel groups, double-blind, on 108 patients, patients are divided into two groups of intervention and control based on a random table. The blocking method is divided into two groups using the sealedenvelop.com website.
Settings and conduct
Children under three years of age referred to Khatam Al-Anbia Eye Specialized Hospital of Mashhad University of Medical Sciences, who are admitted for outpatient probing surgery. The method of concealment will be to use sealed, opaque envelopes
Participants/Inclusion and exclusion criteria
Inclusion criteria: All children under three years old referred to Khatam Al-Anbia Hospital in Mashhad who have outpatient probing Exclusion criteria: Children with underlying psychiatric disorders, Children with underlying illness, Seizure, Parental dissatisfaction, Drug allergy
Intervention groups
The anesthesia intervention group was controlled with intravenous propofol at a dose of 50 to 100 μg / kg and the control group was anesthetized with 2.5% isoflurane.
Main outcome variables
PROPOFOL,ISOFLOURAN,REDUSE POST OPERATIVE AGITATHION
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210525051394N1
Registration date:2021-06-10, 1400/03/20
Registration timing:registered_while_recruiting
Last update:2021-06-10, 1400/03/20
Update count:0
Registration date
2021-06-10, 1400/03/20
Registrant information
Name
Hamideh Zarezadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5525 4480
Email address
zarezadehh971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-06, 1400/03/16
Expected recruitment end date
2021-12-06, 1400/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Isoflurane and Propofol on prevention of emergence agitation in children under 3 having probing surgery
Public title
Comparison of the effect of Isoflurane and Propofol on prevention of emergence agitation in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All children under three years old referred to Khatam Al-Anbia Hospital in Mashhad having probing surgery
Exclusion criteria:
Children with underlying psychiatric disorder
Children with underlying disease
Convulsions
Dissatisfaction of parents
Drug allergy
Age
From 30 days old to 3 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
The blocking method is divided into two groups using the sealedenvelop.com website
Blinding (investigator's opinion)
Double blinded
Blinding description
.The method of concealment will be to use sealed, opaque envelopes . Due to the fact that patients are anesthetized, they are unaware of the type of medicine used and have been blinded. The data analyst is also unaware of the assigned groups at the time of analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad university of medical sciences
Street address
Medical school, Mashhad university of medical sciences, Azadi sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2021-05-30, 1400/03/09
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.083
Health conditions studied
1
Description of health condition studied
agitation
ICD-10 code
R45.1
ICD-10 code description
Restlessness and agitation
Primary outcomes
1
Description
Severity of agitation
Timepoint
preoprative child evaluathion,postoperative and recavery child severity agitathion evaluathion
Method of measurement
Richmond Sedation-Agitation Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Maintenance Anesthesia with hypnotic intravenous drug ( propofol) at a dose of 50 to 100 μg / kg at interoperation time
Category
Prevention
2
Description
Control group: Maintenance Anesthesia with inhalathion anesthetic ( isoflurane)2.5% at interoperation time
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam al anbia hospihal university of mashhad
Full name of responsible person
zarezadehhamideh
Street address
No.55,Ordibehesht Ave,seyed mortaza Blvd,Kashmar Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9671983957
Phone
+98 51 5523 5987
Email
zarezadehh971@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tafaghodi mohsen
Street address
Ghorayshi Bil.Danehgah AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hamideh Zarezadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No.55,Ordibehesht Ave,seyed mortazaBlv
City
Kashmar
Province
Razavi Khorasan
Postal code
9671983957
Phone
+98 51 5525 4480
Fax
Email
zarezadehh971@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamideh Zarezadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
NO .55 .Aveordibehesht.Blvd seyed morteza
City
Kashmar
Province
Razavi Khorasan
Postal code
9671983957
Phone
+98 51 5525 4480
Fax
Email
zarezadehh971@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamideh Zarezadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
NO .55 .Aveordibehesht.Blvd seyed morteza
City
Kashmar
Province
Razavi Khorasan
Postal code
9671983957
Phone
+98 51 5525 4480
Fax
Email
zarezadehh971@mums.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