The aim of this study is to compare the effect of Granisetrone,Ondansetrone and pethidine in the prevention of shivering surgery. In this double-blind clinical trial, 120 patients candidated for surgery (General, Orthopedic and ENT surgeries) under general anesthesia in Ardabil Imam Khomeini Hospital will be enrolled after signing informed consent. The patients will be randomly assigned to receive normal saline 2 ml, pethidine 25 mg,Ondansetrone 4 mg,Granisetrone 40 чg/kg after induction of general anesthesia with the same method. The incidence of shivering and its severity will be recorded by a trained nurse, who is blind regarding the intervention, in the recovery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204284093N4
Registration date:2012-05-25, 1391/03/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-05-25, 1391/03/05
Registrant information
Name
Masood Entezariasl
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1225 1688
Email address
m.entezari@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-06-21, 1392/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study of Granisetron and Ondansetron and petedin for Prevention of Postoperative Shivering: A Randomized Clinical Trial
Public title
A Comparative Study of Granisetron and Ondansetron and petedin for Prevention of Postoperative Shivering: A Randomized Clinical Trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Candidate for surgery (General, Orthopedic and ENT surgeries), general anesthesia, ASA class I-II
Exclusion criteria: history of substance abuse, presence of neuromuscular diseases, hypersensitivity to the study drugs, evidence of grade 3 or 4 of heart failure, fever (more than 37/8 ° orally), history of alpha2-receptor antagonist drugs consumption
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences
City
Ardabi
Postal code
Approval date
2012-03-14, 1390/12/24
Ethics committee reference number
904/1
Health conditions studied
1
Description of health condition studied
shivering
ICD-10 code
R 68.8
ICD-10 code description
Other specified general symptoms and signs
Primary outcomes
1
Description
postoperative shivering
Timepoint
After surgery in recovery room
Method of measurement
Visual analog scale of chills
Secondary outcomes
1
Description
Central and peripheral temperature
Timepoint
Before the intervention, during surgery, in the recovery room after surgery
Method of measurement
Tympanic and environmental Thermometer
Intervention groups
1
Description
Granisetron(40чg//kg, increased volume to 2 ml) before induction of anesthesia
Category
Prevention
2
Description
Ondansetron(4mg, increased volume to 2 ml) before induction of anesthesia
Category
Prevention
3
Description
Pethidine (25 mg, inceased volume to 2 ml) before induction of anesthesia
Category
Prevention
4
Description
Normal Saline, 2 ml, before induction of anesthesia
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr Masood Entezariasl
Street address
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Akbar Pirzadeh
Street address
Ardabil University of Medical Sciences
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Dr Masood Entezariasl
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 45 1772 3010
Fax
Email
m.entezari@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Masood Entezariasl
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 45 1772 3010
Fax
Email
m.entezari@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Masood Entezariasl
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 45 1772 3010
Fax
Email
m.entezari@arums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)