Comparison of emergence agitation frequency in pediatrics candidate for elective hernioraphy under general anesthesia with Sevoflurane and Isoflurane
Design
In this double-blind clinical trial parallel studty (phase 3), children 2 to 6 years old candidate for elective hernioraphy were included. Patients were randomly divided into two groups using a table of random numbers. Maintenance of anesthesia was in a group was with 1.2 MAC of Sevoflurane (n-25) and in the other group with 1.2 MAC of Isoflurane (n = 25) with nitrous oxide and oxygen in both groups.
Settings and conduct
This double-blind clinical trial study aimed to comparison of emergence agitation frequency in pediatrics who candidate for elective hernioraphy under general anesthesia with Sevoflurane and Isoflurane. pediatrics candidate for elective hernioraphy in Urmia Shahid Motahhari hospital were enrolled. the patient, the researcher and the person who assessed the outcomes were blind.
Participants/Inclusion and exclusion criteria
Children aged 2 to 6 years who were candidates for hernioraphy surgery under general anesthesia were included in this study. Children with a history of mental and behavioral disorders since birth, emergency surgeries, having a active disease in the respiratory system, a history of sleep apnea, a history of febrile seizures, developmental disorders and heart disorders were excluded from the study.
Intervention groups
Maintenance of anesthesia was in a group was with 1.2 MAC of Sevoflurane (n-25) and in the other group with 1.2 MAC of Isoflurane (n = 25) with nitrous oxide and oxygen in both groups.
Main outcome variables
emergence agitation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170515033986N2
Registration date:2020-11-23, 1399/09/03
Registration timing:retrospective
Last update:2020-11-23, 1399/09/03
Update count:0
Registration date
2020-11-23, 1399/09/03
Registrant information
Name
Nazli Karami
Name of organization / entity
Urmia University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9932
Email address
karami.n@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2019-02-19, 1397/11/30
Trial completion date
2019-02-19, 1397/11/30
Scientific title
Comparison of emergence agitation frequency in pediatrics candidate for elective hernioraphy under general anesthesia with Sevoflurane and Isoflurane
Public title
The effect of Sevoflurane and Isoflurane on emergence agitation of children under hernioraphy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 2 to 6 years
Pediatrics candidate for inguinal hernioraphy under general anesthesia
Exclusion criteria:
History of mental and behavioral disorders since birth
Having an active disease in the respiratory system
History of sleep apnea
Developmental disorders and cardiac disorders
History of febrile seizures
Age
From 2 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into two groups using a table of random numbers. firstly a number was randomly selected from the table and moving from top to bottom in the table continued. the numbers between 01 to 25 were assigned to the Sevoflurane group and the numbers between 26 to 50 were assigned to the Isoflurane group. according to the determined sample size (50 patient), as regards the number of last patient was 50 so that the numbers greater than 50 were ignored.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient, the researcher and a person who assessed the outcomes were blind to the belonging of the patient to the Isoflurane or Sevoflurane group.in the operating room the anesthetics of Sevoflurane and Isofuran were covered with a cloth during surgery so that the type of prescribed anesthetic could not be detected during the surgery.Therefore, the researcher did not know about the type of anesthetic prescribed to the patient. The person who assessed the outcomes was an anesthesia technician other than researcher that did not know the type of prescribed anesthetics for each patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences; Resalat street; Jahad Blvd; Urmia; Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-09-05, 1397/06/14
Ethics committee reference number
IR.UMSU.REC.1397.200
Health conditions studied
1
Description of health condition studied
Emergence agitation
ICD-10 code
R45.1
ICD-10 code description
Restlessness and agitation
Primary outcomes
1
Description
Emergence agitation
Timepoint
10 minutes, 20 minutes and 30 minutes after surgery