Comparison of Post-anesthetic Administration of Propofol and Midazolam in Prevention of Post-extubation Agitation after Isoflurane Anesthesia in Children undergoing Tonsillectomy
Comparison of post-anesthetic administration of propofol and midazolam in prevention of post-extubation agitation after Isoflurane anesthesia in children undergoing tonsillectomy
Design
Randomized, controlled, parallel group trial with blinded outcome assessment. Randomization was centralized with simple randomization with random number tables
Settings and conduct
Patients, researchers responsible for data collection and analyses are blind to the groups allocation
Participants/Inclusion and exclusion criteria
Inclusion criteria: children aged 3 to 15 years old, anesthesia risk classification of ASA class of I or II, and obtaining written consent from the parents; Exclusion criteria: no consent from the parent, children with cognition diseases, children with delayed growth factors
Intervention groups
Ninety patients are randomly divided into two intervention groups and one control group (each 30 cases). In the Intervention group (1), Immediately before termination of isoflurane administration, midazolam with 0.03 mg/kg dosage is administered. In the Intervention group (2), Immediately before termination of isoflurane administration, midazolam with 1 mg/kg dosage is administered. In the control group, immediately before termination of isoflurane administration, normal saline is administered
Main outcome variables
The level of agitation is assessed according to PAED scale at 5, 10, 20 and 30 minutes after the drug administration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180811040764N1
Registration date:2018-08-20, 1397/05/29
Registration timing:registered_while_recruiting
Last update:2018-08-20, 1397/05/29
Update count:0
Registration date
2018-08-20, 1397/05/29
Registrant information
Name
Masoome Mahdavi Rad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3292 3589
Email address
mahdavirad.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-08, 1397/05/17
Expected recruitment end date
2018-11-08, 1397/08/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Post-anesthetic Administration of Propofol and Midazolam in Prevention of Post-extubation Agitation after Isoflurane Anesthesia in Children undergoing Tonsillectomy
Public title
Propofol and Midazolam Effects on Agitation Prevention after Isoflurane Anesthesia in Children Candidate of Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 3 to 15 years old
American Society of Anesthesiologists (ASA) classification I, II
Obtaining written consent form from parent
Exclusion criteria:
Children with cognition diseases
Children with delayed growth factors
Age
From 3 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random number tables
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, responsible for collecting data, data analyzer
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Golestan Blvd., Research deputy, Ahvaz Jundishapur University Of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-02-03, 1396/11/14
Ethics committee reference number
IR.AJUMS.REC.1396.948
Health conditions studied
1
Description of health condition studied
tonsillitis
ICD-10 code
J35
ICD-10 code description
Chronic diseases of tonsils and adenoids
Primary outcomes
1
Description
Agitation level
Timepoint
5, 10, 20 and 30 minutes after injection medication
Intervention group (1): Immediately before termination of isoflurane administration, midazolam with 0.03 mg/kg dosage is administered, Intervention group (2): Immediately before termination of isoflurane administration, midazolam with 1 mg/kg dosage is administered.
Category
Treatment - Drugs
2
Description
Control group: Immediately before termination of Isoflurane administration, normal saline is administered
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mahbobe Rashidi
Street address
Azadegan Ave., Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 2925
Email
m.rashidi8655@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi, PhD
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
PAIN-9612
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Masoome Mahdavi Rad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Azadegan Ave., Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61329235893
Email
Masi.mahdavi2015@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahbobe Rashidi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
ICU Fellowship
Street address
Azadegan Ave., Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61322235292
Email
m.rashidi8655@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Masoome Mahdavi Rad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Azadegan Ave., Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61329235893
Email
Masi.mahdavi2015@gmail.com
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