The aims of this study it to determine the efficacy of ketamine and tramadol in preventig post_operative shivering. This study will be done as a double-blind randomized controlled clinical trial. Inclusion and exclusion criteria: 1) Age range of 18-65 2) BMI<30 3)No history of seizur or multiple allergia 4)No history of cardiovascular diseases HTN
Exclusion:
1)Any patient need blood or blood supply transfusionduring surgery
2)Body temperature below 35 durin the surgery
Each patient will be given a code according to the place where he or she stands in our list and depending on the given code, they will enter in one of the control (S: normal salin) or ketamine (K) or tramadol (T) groups (Total=150).
We will inject 2 cc normal salin to group S, 0.5 mg/kg ketamin to group K and 0.3 mg/kg tramadol to groupe T 0.5 hour before finishing the surgery. Post-operative shivering will be evaluated by crosly scale and post-operative pain will be evaluated by VAS score.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011164819N2
Registration date:2011-07-27, 1390/05/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-27, 1390/05/05
Registrant information
Name
Saied Morteza Heidari Tabaei Zavareh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1267 6415
Email address
m_heidari@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of efficacy of intravenous ketamine and tramadol in preventing post-operative shivering in general anesthetic patients
Public title
Comparison of efficacy of ketamine and tramadol in preventing post-operative shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Aged between 18 and 65; BMI less than 30; No history of seizur or multiple allergia; No history of cardiovascular diseases HTN
Exclusion criteria: needs to blood or blood supply transfusion during surgery
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Isfahan University of Medical Sciences
Street address
Isfahan - Hezarjerib St.
City
Isfahan
Postal code
Approval date
2010-02-24, 1388/12/05
Ethics committee reference number
388568
Health conditions studied
1
Description of health condition studied
post_operative shivering
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia
Primary outcomes
1
Description
Tympanic temperatur
Timepoint
Before induction of anesthesia - After induction of anesthesia - 30 min. after induction of anesthesia - At the time of entering to recovery - 15 min. after - 30 min. after
Method of measurement
With digital tympanic thermometer
2
Description
Axillary temperature
Timepoint
Before induction of anesthesia - After induction of anesthesia - 30 min. after induction of anesthesia - At the time of entering to recovery - 15 min. after - 30 min. after
Method of measurement
Mercuric Thermometer
Secondary outcomes
1
Description
VAS Score of pain
Timepoint
At entering to recovery - 15 min. later - 30 min. later
Method of measurement
VAS Score bethween 0-10
2
Description
VAS Score of nausea
Timepoint
In recovery room - During 24 hours later
Method of measurement
VAS Score of nausea bethween 0-10
3
Description
vomiting
Timepoint
In recovery room - During 24 hours later
Method of measurement
Frequency
4
Description
Dizziness
Timepoint
In recovery room
Method of measurement
Observation & asking the patient
5
Description
Headache
Timepoint
In recovery room
Method of measurement
Observation & asking the patient
6
Description
Halucination
Timepoint
In recovery room
Method of measurement
Observation
7
Description
Recovery stay time
Timepoint
End of recovery stay
Method of measurement
Minute
Intervention groups
1
Description
In second group, 30 min. before finishing anesthesia we will inject 0.5 mg/kg of ketamine intravenusely
Category
Treatment - Drugs
2
Description
In third group, we will inject 2 cc N/S IV, 30 min. before finishing anesthesia.
Category
Placebo
3
Description
In First group, we will inject 0.3 mg/kg of tramadol IV, 30 min. before finishing anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospial
Full name of responsible person
Saied Morteza Heidari - Anesthesiologist - assistent professor
Street address
Hezar jarib Aven-Isfahan University Of Medical Sciences and Health Services-Isfahan-Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Saied Morteza Heidari Tabaei Zavareh
Street address
Hezar jarib Aven-Isfahan University Of Medical Sciences and Health Services-Isfahan-Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Saied Morteza Heidari Tabaei Zavareh
Position
Assistant Professor - Anesthesiologist
Other areas of specialty/work
Street address
Hezar jarib Aven-Isfahan University Of Medical Sciences and Health Services-Isfahan-Iran
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
m_heidari@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Saied Morteza Heidari Tabaei Zavareh
Position
Assistant Professor - Anesthesiologist
Other areas of specialty/work
Street address
Hezar jarib Aven-Isfahan University Of Medical Sciences and Health Services-Isfahan-Iran
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
m_heidari@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ali noroozi
Position
M.D
Other areas of specialty/work
Street address
Hezar jarib Aven-Isfahan University Of Medical Sciences and Health Services-Isfahan-Iran
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
Dr.alinoroozi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)