Aim of this study is to Compare intravenous anesthetic agents to provide fast-acting relief of minor orthopedic surgery. Inclusion criteria: ASA I and II, during surgery less than 30 minutes, age 18 - 65.Exclusion criteria: during surgery more than 30 minutes; allergy to drugs used in this study; drug abuse; use sedation’s drug 90 patients were randomly divided into two groups. The first group inject Ketamine 0.5 mg/ kg and Propofol 0.5 mg/ kg.The second group inject ketamine 0.5 mg/ kg and Thiopental 50-75 mg. Researcher recorded vital sign and number of BIS monitoring every 5 minutes during surgery. Researcher recorded pain with visual analogue scale( VAS )after surgery. Researcher recorded recovery time for all patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016032320258N6
Registration date:2016-05-15, 1395/02/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-15, 1395/02/26
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University Of Medical Sciences
Expected recruitment start date
2015-07-21, 1394/04/30
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare intravenous anesthetic agents to provide fast-acting in minor orthopedic surgery
Public title
Compare intravenous anesthetic agents to provide fast-acting in minor orthopedic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA I and II; during surgery less than 30 minutes; age 18- 65
Exclusion criteria: during surgery more than 30 minutes; allergy to drugs used in this study; drug abuse; use of sedation drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
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
Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij Squre ,Sardasht,Arak
City
Arak
Postal code
Approval date
2015-06-21, 1394/03/31
Ethics committee reference number
IR.ARAKMU.REC.1394.42
Health conditions studied
1
Description of health condition studied
Minor orthopedic surgery
ICD-10 code
M84.3
ICD-10 code description
Stress fracture, not elsewhere classified
Primary outcomes
1
Description
Pulse of heart
Timepoint
every 5 minutes until the end of surgery
Method of measurement
count
2
Description
Respiratory
Timepoint
Every 5 minutes until the end of surgery
Method of measurement
Count
3
Description
Temperature
Timepoint
Every 5 minutes until the end of surgery
Method of measurement
Thermometer
4
Description
Blood pressure
Timepoint
every 5 minutes until the end of surgery
Method of measurement
Barometer
5
Description
Bispectral index
Timepoint
every 5 minutes until the end of surgery
Method of measurement
connection of electrode
6
Description
Pain
Timepoint
After operation
Method of measurement
Visual Analogue Scale
7
Description
Recovery time
Timepoint
After operation
Method of measurement
Minute
Secondary outcomes
empty
Intervention groups
1
Description
First group of patients inject Ketamine 0.5 mg/ kg and Propofol 0.5 mg/ kg
Category
Treatment - Drugs
2
Description
Second group inject ketamine 0.5 mg/ kg and Thiopental 50-75 mg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Hanie Kianipour
Street address
Valiasr Hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research, Arak University Of Medical Science
Full name of responsible person
Dr Mohammad Rafiee
Street address
Vice Chancellor For Research, Arak University Of Medical Science
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research, Arak University Of Medical Science