Efficacy of intravenous infusion of Dexmedetomidine in the first ten minutes of surgery in comparison with last ten minutes of surgery on post operative agitation in 9 to 96 months aged children undergoing oral surgery
Objective: To evaluate the efficacy of intravenous infusion of Dexmedetomidine in the first ten minutes of surgery in comparison with last ten minutes of surgery on post operative agitation in children undergoing oral surgeries Design: Single blind randomized clinical trial Setting: Children undergoing oral surgeries in Mofid Children Hospital
Inclusion criteria: patients with class 1 according to the American Society of Anesthesiology (ASA) scoring criteria; Age of 9 months to 96 months
Exclusion criteria: Parental disagreement Intervention: Eighty children undergoing oral surgeries will be randomly allocated to one of the two parallel groups. In the group 1 after induction of anesthesia Dexmedethomidine will be started with 1 μg/kg intravenous infusion during 10 minutes. In the group 2 Dexmedethomidine will be started with 1 μg/kg intravenous infusion during 10 minutes in the last ten minutes of surgery. Anesthesia method is similar between two groups.
Primary outcome: Level of agitation in the recovery room using Ramsay scale
Secondary outcome: Mean arterial blood pressure every 5 minutes; Heart rate every 5 minutes; Anesthesia time; Surgical time; Extubation time; Recovery time; Severity of pain in the recovery room using FLACC (Face, Legs, Activity, Cry, Consolability) pain scale
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122031497N1
Registration date:2017-03-31, 1396/01/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-31, 1396/01/11
Registrant information
Name
Afsaneh Sadeghi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2290 8383
Email address
af.sadeghi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-01-21, 1395/11/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of intravenous infusion of Dexmedetomidine in the first ten minutes of surgery in comparison with last ten minutes of surgery on post operative agitation in 9 to 96 months aged children undergoing oral surgery
Public title
The effect of Dexmedethomidine on post operative agitation in children undergoing oral surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with class 1 according to the American Society of Anesthesiology (ASA) scoring criteria; Age of 9 months to 96 months
Exclusion criteria: Parental disagreement
Age
From 9 months old to 8 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak Ave
City
Tehran
Postal code
1916964913
Approval date
2016-10-31, 1395/08/10
Ethics committee reference number
ir.sbmu.msp.rec.1395.281
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
Agitation
Timepoint
َAfter surgery in the recovery room
Method of measurement
Ramsay sedation scale
Secondary outcomes
1
Description
Mean arterial blood pressure
Timepoint
Every five minutes
Method of measurement
Millimeter of mercury announced by vital sign monitoring system
2
Description
Heart rate
Timepoint
Every five minutes
Method of measurement
Heart rate announced by vital sign monitoring system
3
Description
Anesthesia time
Timepoint
Start of induction of anesthesia until extubation
Method of measurement
Minute
4
Description
Surgical time
Timepoint
Since the start of the operation until the end of the operation
Method of measurement
Minute
5
Description
Extubation time
Timepoint
After discontinuation of anesthetic gas until extubation
Method of measurement
Minute
6
Description
Recovery time
Timepoint
From entrance of patient to recovery room until discharge from recovery room