The purpose of this study will be to assess evaluation the effect of dexmedetomidine on emergence agitation in children undergoing anesthesia with sevoflurane
Design
Clinical trial with two arm parallel groups, randomised trial with double blinded assessment. Study phase will be 3-2
Settings and conduct
In Urmia Imam Khomeini hospital operating room Group D (Study group) will be received intravenous dexmedetomidine 0.5 microgram per kilogram in 10 minutes and Group C (control group) will be received intravenous saline 0.9% after induction of general anesthesia. After arrival to postanesthesia care unit (PACU), incidence of emergence agitation and pain will be assessed through six time points(after extubation, leaving the OR, on admission to PACU, 10, 20, and 30 min after arrival in PACU by four‑point agitation scale and visual analog scale.
Participants/Inclusion and exclusion criteria
Inclusion criteria: those between 2 and 8 years of age؛ classified as ASA status I؛ scheduled for either an adenoidectomy alone or both an adenoidectomy and tonsillectomy؛ general anesthesia
Exclusion criteria included: mental retardation or developmental delay؛ neurologic disease؛ a history of asthma or the other lung diseases؛ chronic cough؛ upper respiratory tract infection within 4 weeks of surgery؛ patients with abnormal airway.
Intervention groups
Intervention group: will be received intravenous dexmedetomidine 0.5 microgram per kilogram in 10 minutes after induction of anesthesia
Control group: will be received intravenous saline 0.9% after induction of genera
Main outcome variables
agitation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160430027677N14
Registration date:2019-05-07, 1398/02/17
Registration timing:registered_while_recruiting
Last update:2019-05-07, 1398/02/17
Update count:0
Registration date
2019-05-07, 1398/02/17
Registrant information
Name
Shahryar Sane
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 4897
Email address
sane.sh@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of dexmedetomidine on emergence agitation in children undergoing anesthesia with sevoflurane
Public title
The effect of dexmedetomidine on emergence agitation after anesthesia with sevoflorane
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
2 to 8 years old
American society of Anesthesiology physical status I
adenoidectomy alone or both an adenoidectomy and tonsillectomy
general anesthesia with sevoflurane
Exclusion criteria:
mental retardation or developmental delay
neurologic disease
history of asthma or the other lung diseases
chronic cough, upper respiratory tract infection within 4 weeks of surgery
patients with abnormal airway
Age
From 2 years old to 8 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Seventy patients who recruited as eligible population and assigned to one of two groups(35 patients in each group) by using Random Allocation Software 2.0. Group D (Study group) will be received intravenous dexmedetomidine 0.5 microgram per kilogram and Group C (control group) will be received intravenous saline 0.9%
Blinding (investigator's opinion)
Double blinded
Blinding description
Dose calculation, drug preparation, and administration will be done by attending anesthesiologist who is not involved or have not participated in this trial.after collecting information from the anesthesia residents, the anesthesiologist will be informed of the group each patient will be assigned to.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Urmia University of Medical Sciences
Street address
Emergent Street, Ershad Avenue
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2019-01-16, 1397/10/26
Ethics committee reference number
IR.UMSU.REC.1397.411
Health conditions studied
1
Description of health condition studied
بی قراری
ICD-10 code
R45.1
ICD-10 code description
Restlessness and agitation
Primary outcomes
1
Description
agitation
Timepoint
After extubation, leaving the OR, on admission to PACU, 10, 20, and 30 min after arrival in PACU
Method of measurement
four-point scale
Secondary outcomes
1
Description
pain
Timepoint
After extubation, leaving the OR, on admission to recovery, 10, 20, and 30 min after arrival in recovery
Method of measurement
face leg activity cry consolability
2
Description
Mean arterial pressure
Timepoint
Minutes 5, 10, 15 and 20 during surgery
Method of measurement
None invasive barometer pressure
3
Description
Heart rate
Timepoint
Minutes 5, 10, 15 and 20 during surgery
Method of measurement
Electrocardiogram
Intervention groups
1
Description
Intervention group: will be received intravenous dexmedetomidine 0.5 microgram per kilogram in 10 minutes after induction of anesthesia
Category
Prevention
2
Description
Control group: will be received intravenous saline 0.9% after induction of general anesthesia
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khomeini Hospital, operating room B
Full name of responsible person
Shahryar Sane
Street address
Ershad Avenue, Modarres Avenue
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3346 9931
Fax
+98 44 3346 8967
Email
emam-h-urm@umsu.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Emergent Street, Ershad Avenue
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3223 4897
Email
research@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emergrnt Street, Resalat Avenue
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3346 8967
Email
sanesh@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emergrnt Street, Resalat Avenue
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3346 8967
Email
sanesh@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emergent Street, Ershad Avenue
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3346 8967
Email
sanesh@umsu.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