Study of the effect of Dexmedetomidine Premedication on Pediatric Tonsillectomy Anesthesia
Design
This study is one-blinded clinical trial. The study population will be included all children aged 4-10 years who are candidates for Tonsillectomy referring to the ENT ward of Imam Khomeini hospital of Kermanshah city.44 eligible patients will be selected conveniently and randomly will be assigned to intervention and control groups.
Settings and conduct
This study which will be conducted in Imam Khomeini hospital of Kermanshah city is one-blinded one that the participants will not know what medicine they will receive. At the beginning of the study, the severity of the sensory symptoms, including paresthesia and pain, is recorded in a checklist in both groups.The bleeding, nausea, vomiting, agitation will be investigated after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria:4-10 years old children undergoing tonsillectomy.
Exclusion criteria:
Sensitization to opioids or local anesthetics; Patients suffering from asthma, kidney disease, liver, acute pharyngitis and coagulation disorders
Intervention groups
The intervention group will receive 200micrograms of Dexmedetomidine as infusion at a rate of 0.5 µg/kg/ h in addition to intravenous thiopental 5 mg / kg with atracurium 0.5 mg / kg.the control group only to intravenous thiopental with 0.5 mg / kg atracurium will receive 5 mg / kg .
Main outcome variables
Bleeding, nausea and vomiting, agitation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N108
Registration date:2018-12-15, 1397/09/24
Registration timing:prospective
Last update:2018-12-15, 1397/09/24
Update count:0
Registration date
2018-12-15, 1397/09/24
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-31, 1397/10/10
Expected recruitment end date
2019-03-01, 1397/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of Dexmedetomidine Premedication on Pediatric Tonsillectomy Anesthesia
Public title
Study of the effect of Dexmedetomidine Premedication on Pediatric Tonsillectomy Anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
4-10 years old children undergoing tonsillectomy
Exclusion criteria:
Sensitization to opioids or local anesthetics
Patients suffering from asthma, kidney disease, liver, acute pharyngitis and coagulation disorders
Age
From 4 years old to 10 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study patients were blinded to the study groups,dosage of the drug and the manufacturer of the drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-09-11, 1397/06/20
Ethics committee reference number
ir.kums.rec.1397.421
Health conditions studied
1
Description of health condition studied
Tonsillectomy
ICD-10 code
28.92
ICD-10 code description
tonsillectomy
Primary outcomes
1
Description
Nausea and Vomiting
Timepoint
After surgery
Method of measurement
Ask the patient and doctor's observation
2
Description
Agitation
Timepoint
After surgery
Method of measurement
doctor's observation
3
Description
Bleeding
Timepoint
After surgery
Method of measurement
doctor's observation
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive 200micrograms of Dexmedetomidine as infusion at a rate of 0.5 µg/kg/ h in addition to intravenous thiopental 5 mg / kg with atracurium 0.5 mg / kg.
Category
Treatment - Drugs
2
Description
The control group only to intravenous thiopental with 0.5 mg / kg atracurium will receive 5 mg / kg .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Gholamreza Rodaber
Street address
Street, Emam Khomeini Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3727 9104
Email
Saeidrood@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Gholamreza Roodaber
Position
Resident of Anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 83 3728 3602
Email
Saeidrood@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Bahman Roshani
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 83 3427 4618
Email
bRoshani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Gholamreza Roodaber
Position
Resident of Anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 83 3427 4618
Email
Saeidrood@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail