The aim of this study was to compare the effect of sevoflurane with and without propofol for laryneal mask airway insertion in children.
Design
A clinical trial with parallel, double-blind, randomized by randomizer website, phase 3 was performed on 36 patients in both equal groups.
Settings and conduct
Phase 3 clinical trial with two parallel groups was performed on 36 patients referred to Shahid Motahari Hospital in Urmia. Patients were enrolled in two equal groups (sevoflurane with propofol group = 18 people and sevoflurane without propofol group = 18 people). In this study, patients and clinical assessor as well as statistical analyzers were unaware of group assignment. Randomization was done by randomizer website.
Participants/Inclusion and exclusion criteria
Inclusion criteria were age between 2 to 8 years old, American Society of Anesthesiologists (ASA) I and II and abdominal and lower limb surgeries. Exclusion criteria were dissatisfaction of parents to participate in the study, the possibility of surgery with spinal anesthesia.
Intervention groups
Intervention group: In this group, sevoflurane with propofol was used before inserting laryngeal mask in children. Control group: In this group, sevoflurane without propofol was used before inserting laryngeal mask in children.
Main outcome variables
Time to reach the desired relaxation for laryngeal mask insertion, heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201207049639N5
Registration date:2021-01-09, 1399/10/20
Registration timing:retrospective
Last update:2021-01-09, 1399/10/20
Update count:0
Registration date
2021-01-09, 1399/10/20
Registrant information
Name
Hadi Houshyar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
hooshyar.h@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-22, 1399/04/02
Expected recruitment end date
2020-11-29, 1399/09/09
Actual recruitment start date
2020-06-24, 1399/04/04
Actual recruitment end date
2020-11-30, 1399/09/10
Trial completion date
2020-11-30, 1399/09/10
Scientific title
Comparison of sevoflurane with and without propofol for laryneal mask airway insertion in children; a double-blinded clinical trial
Public title
Effect of sevoflurane and propofol for laryneal mask airway insertion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 2 to 8 years old
American Society of Anesthesiologists (ASA) I and II
Abdominal and lower limb surgeries
Exclusion criteria:
Dissatisfaction of parents to participate in the study
Possibility of surgery with spinal anesthesia
Age
From 2 years old to 8 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
36
Actual sample size reached:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Candidate children for abdominal and lower limb surgery were randomly divided into two groups receiving sevoflurane with and without propofol using https://www.randomizer.at/.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients were unaware of their placement in the intervention groups and the statistical analyzer received the data in code, not the actual grouping.
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 Ave., Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2019-06-19, 1398/03/29
Ethics committee reference number
IR.UMSU.REC.1398.107
Health conditions studied
1
Description of health condition studied
Laryneal mask airway insertion in children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Time to reach the desired relaxation for laryngeal mask insertion
Timepoint
Due to the nature of the variable under study, which is time, only once from the time of administration of sevoflurane to the desired relaxation was considered
Method of measurement
Timer by second
Secondary outcomes
1
Description
Heart rate
Timepoint
Once during laryngeal mask insertion
Method of measurement
Pulsoximeter
Intervention groups
1
Description
Intervention group: Patients in the intervention group underwent induction of anesthesia with 8% sevoflurane with oxygen and N2O in equal proportions. The criterion of anesthesia was the disappearance of the eyelid reflex. Laryngeal mask was inserted 90 second after anesthesia by skilled person. During this time, the patient received only 8% sevoflurane with oxygen and N2O in equal proportions annd 1 mg/kg propoful (Produced by ABIAN Pharmed).
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group underwent induction of anesthesia with 8% sevoflurane with oxygen and N2O in equal proportions. The criterion of anesthesia was the disappearance of the eyelid reflex. Laryngeal mask was inserted 90 second after anesthesia by skilled person. During this time, the patient received only 8% sevoflurane with oxygen and N2O in equal proportions.