The aim of this study was to compare the effects of three intravenous dexametasone, ondasetrone and magnesium sulfate on shivering after general anesthesia in orthopedic surgery. The study was carried out on 90 patients referred for elective surgery under general anesthesia in orthopedic surgery. Patients were randomly allocated into the three groups of ondasetrone, dexametasone, and magnesium sulfat. Patients received injection of dexametasone 8 mg, ondaserone 8 mg and 30 mg/kg of magnesium sulfate 2 hours before surgery. After injection, we were measured shivering in recovery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012100510340N7
Registration date:2012-11-13, 1391/08/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-13, 1391/08/23
Registrant information
Name
Mohammad Aryaie
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 277 1798
Email address
aryaie@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Sciences
Expected recruitment start date
2010-05-18, 1389/02/28
Expected recruitment end date
2012-03-10, 1390/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of dexamethasone, ondansetron and magnesium sulfate on post operation shivering in general anesthesia after orthopedic surgery
Public title
The comparison of three drugs, Ondnasetrone, Dexametasonel and Magnesium Sulfate
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: age of 18 to 55 years; ASA1, 2; none shivering before surgery. Exclusion Criteria: Hypertension; allergies to medicines, ondasetrone, sufentanil, and magnesium sulfate; Drug addiction; cerebrovascular disease.
Age
From 18 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan university of medical sciences
Street address
Golestan University of Medical Sciences, Gorgan road 2 km Sari
City
Gorgan
Postal code
Approval date
2010-05-08, 1389/02/18
Ethics committee reference number
01389.02.018
Health conditions studied
1
Description of health condition studied
Shivering
ICD-10 code
T80-T88
ICD-10 code description
Complications of surgical and medical care, not elsewhere classified
Primary outcomes
1
Description
shivering
Timepoint
after surgery
Method of measurement
observation
Secondary outcomes
1
Description
pain
Timepoint
after surgery
Method of measurement
VAS (Visual Analog Scale)
Intervention groups
1
Description
8 mg dexamethasone IV
Category
Treatment - Drugs
2
Description
8 mg Ondanstrone IV
Category
Treatment - Drugs
3
Description
30 mg/kg Magnesium Sulfate IV
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan universty of medical sciences
Full name of responsible person
Street address
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan university of medical sciences
Full name of responsible person
Mohammad Ali Vakili
Street address
Golestan university of medical sciences, third floor
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan 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
anesthesiology Community
Full name of responsible person
Kazem Kazem nejad
Position
anesthesiology
Other areas of specialty/work
Street address
fifth Azar hospatil, fifth street, kakh sq.
City
Gorgan
Postal code
Phone
+98 17 1442 1651
Fax
Email
kazenejad1341@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan university of medical sciences
Full name of responsible person
Mohamad Aryaie
Position
Master
Other areas of specialty/work
Street address
Golestan university of medical sciences, third floor
City
Gorgan
Postal code
Phone
+98 17 1442 4377
Fax
Email
Aryaie_m2009@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Amin Hassanzad
Position
Bachelar
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
hassanzad_amin@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)