The aim of this study is to analyze efficacy of Ketamine in reduction of shivering during spinal anesthesia in patients who are admitted for orthopedic surgery, urology surgery and general surgery and have anesthesia risk of 1 , 2 and 3 and referred to operation room of Shahid Rajaee Hospital, Qazvin, Iran. Patients with age, gender, type of surgery and the same anesthesia risk are divided into two groups (control and trial). Each group includes 146 (total 292). After doing spinal anesthesia, putting the patient in the proper position of surgery, in the trial group 0.2mg/kg of Ketamine are injected intravenously. In control group, placebo (distilled water), in equal volume to Ketamine, are injected intravenously. Then the patients would be supervised by observers and the results of observations (shivering grades) are recorded in questionnaire forms. This is a doubled blind study and injectors and observers are not aware of injection contents.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903114084N1
Registration date:2010-11-04, 1389/08/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-11-04, 1389/08/13
Registrant information
Name
Habibolloh Mehdipoor
Name of organization / entity
Qazvin university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1333 8034
Email address
hmehdipoor@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Health and allied health faculty, Qazvin University of Medical sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Ketamine in reduction of shivering during spinal anesthesia in orthopedic, urology and general surgeries
Public title
Efficacy of Ketamine in reduction of shivering during spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with orthopedic, urology or general surgeries. Exclusion criteria: patients with anesthesia risk above 3.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
292
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
Qazvin University of Medical Sciences
Street address
Shahid bahonar Blvd., Rasht square
City
Qazvin
Postal code
3419915315
Approval date
empty
Ethics committee reference number
1606 / 20 / د
Health conditions studied
1
Description of health condition studied
shivering
ICD-10 code
R25
ICD-10 code description
Abnormal involuntary movements
Primary outcomes
1
Description
shivering
Timepoint
every 5 min.
Method of measurement
Observational Grade
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ketamine 0.2mg/kg /iv after placing patient on surgical position
Category
Prevention
2
Description
Control group: placebo is injecting in equal volume of Ketamine intravenously after placed patient on surgical position.