Comparing the effect of propofol and thiopental on emergence agitation after anesthesia with isoflurane in Children undergoing adenotonsillectomy surgery.
The aim of this study was to compare the effect of thiopental and propofol on the emergence agitation due to anesthesia maintained by isoflurane. This single blind randomized clinical trial study was done in valiasr hospital of Birjand University of Medical Sciences on 40 patients between 3 to 9 years who were scheduled for adenotonsilectomy surgery under general anesthesia, allocated in two groups according to the type of hypnotic used for induction of anesthesia, thiopental 5 mg/kg, propofol 2 mg/kg. In each of two groups regardless of the type of hypnotic fentanyle 2 µg/kg and atracurium 0.5 mg/kg were administered and isoflurane 1.5% were used for maintenance of anesthesia. Emergence agitation was compared between two groups according to modified objective of pain score (MOPS) at 15, 30 minutes and 2, 4, 6 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060121383N6
Registration date:2016-07-16, 1395/04/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-16, 1395/04/26
Registrant information
Name
Amir Saber Tanha
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3243 2778
Email address
dr.saber@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Birjand University of Medical Sciences.
Expected recruitment start date
2016-05-24, 1395/03/04
Expected recruitment end date
2016-08-25, 1395/06/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of propofol and thiopental on emergence agitation after anesthesia with isoflurane in Children undergoing adenotonsillectomy surgery.
Public title
The effect of propofol on isoflurane induced emergence agitation.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all patients aged 3 to 9 years who were scheduled for adenotonsillectomy surgeries under general anesthesia maintained by isoflurane.
Exclusion criteria: all patients with history of allergic reactions to egg or soy beans; positive familial history of malignant hyperthermia; psychological disorders or any history of usage of sedative or hypnotic drugs; attention deficit hyperactivity disorder.
Age
From 3 years old to 9 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study was randomized by table of random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand.
City
Birjand
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2016-05-23, 1395/03/03
Ethics committee reference number
Ir.bums.1395.9
Health conditions studied
1
Description of health condition studied
Emergent agitation
ICD-10 code
R45.1
ICD-10 code description
Restlessness and agitation
Primary outcomes
1
Description
Agitation
Timepoint
15, 30 minutes and 2, 4, 6 hours after surgery
Method of measurement
Modified Objective Pain Score (MOPS)
Secondary outcomes
empty
Intervention groups
1
Description
Administration Of propofol 2mg/kg
Category
Prevention
2
Description
Administration Of thiopental 5mg/kg
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital of Birjand University of Medical Sciences
Full name of responsible person
Dr. Amir Saber Tanha
Street address
Valiasr hospital, Ghafari Street, Birjand
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Birjand University of Medical Sciences
Full name of responsible person
Dr. Asghar Zarban
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand.
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Amir Saber Tanha
Position
Assisstant professor of anesthesia
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand.
City
Birjand
Postal code
Phone
+98 56 3243 2778
Fax
Email
amirsaber63@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Amir Saber Tanha
Position
Assistant professor of anesthesia
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand
City
Birjand
Postal code
Phone
+98 56 3243 2778
Fax
Email
amirsaber63@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Amir Saber Tanha
Position
Assistant professor of anesthesia
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand
City
Birjand
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)