The objective of this study is to investigate the effect of oral clonidine on the post-operative shivering. A total of 60 patients admitted in the Sina hospital and were candidate of general anesthesia for elective surgery were recruited and allocated into intervention or control group. The patients in the intervention and control group received 0.2 mg clonidine and placebo, respectively, two hours prior to the surgery. Two groups were evaluated in terms of incidence and intensity of shivering.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902083773N2
Registration date:2011-01-13, 1389/10/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-13, 1389/10/23
Registrant information
Name
Farsad Imani
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 4469 0816
Email address
imanifar@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2004-08-31, 1383/06/10
Expected recruitment end date
2005-08-31, 1384/06/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of oral Clonidine effects on prevention of post-anesthesia shivering
Public title
Evaluation of oral Clonidine effects on prevention of post-anesthesia shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age 16-80 years, A.S.A I-II, elective surgery,
Exclusion criteria: Hypotension (B.P. < 80 mmHg), hypertensive (B.P.> 140/95 mmHg), cardiac, renal or liver disease, addiction, previous clonidine usage, pregnancy
Age
From 16 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences-
Street address
Ghods St., Keshavarz Bvd.
City
Tehran
Postal code
Approval date
2010-08-01, 1389/05/10
Ethics committee reference number
89/S/130/629
Health conditions studied
1
Description of health condition studied
post-anesthesia shivering
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
shivering
Timepoint
End of Anesthesia (Recovery room)
Method of measurement
Crossley & Mahajan shivering score
Secondary outcomes
1
Description
Mean blood pressure
Timepoint
During operation
Method of measurement
sphygmomanometer
2
Description
SpO2
Timepoint
During operation
Method of measurement
Pulse oximtry
3
Description
Heart rate
Timepoint
During operation
Method of measurement
Cardiac monitoring
4
Description
Emergence from anesthesia
Timepoint
At the end of anesthesia
Method of measurement
Time (minute) emergence from anesthesia
Intervention groups
1
Description
0.2 milligram clonidine tablet will be administered to intervention group before the anesthesia.
Category
Treatment - Drugs
2
Description
Placebo tablet will be administered to control group before the anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Farsad Imani, Anesthesiologist, Assistant professor
Street address
Imam Khomeini St. hasanabad Sq. Sina Hospital. Farsad Imani
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Farsad Imani, Anesthesiologist, Assistant Professor
Street address
Imam Khomeini St. Hasanabad Sq. Sina Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences and Health Services
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
Tehran University of Medical Sciences, Anesthesia Group
Full name of responsible person
Farsad Imani, Anesthesiologist, Assistant Professor
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Enghelab St. befor Enghelab Sq.
City
Tehran
Postal code
1136746911
Phone
+98 66348500
Fax
+98 66348555
Email
imanifar@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farsad Imani M.D. Assistant Professor of Anesthesiology
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Imam Khomeini St. Hasanabad Sq. Sina Hospital
City
Tehran
Postal code
1136746911
Phone
+98 66 3485 0010
Fax
+98 66348555
Email
imanifar@tums.ac.ir
Web page address
www.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farsad Imani M.D.
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Imam Khomeini St. Hasanabad Sq. Sina Hospital
City
Tehran
Postal code
1136746911
Phone
+98 66 3485 0010
Fax
+98 66348555
Email
imanifar@tums.ac.ir
Web page address
www.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)