Main goal:comparison body tempreture changes during knee arthroscopy with Isoflurane and Propofol.
Methode: double blind clinical trial on 40 non addicted patients(18 to 50 year )and hemodynamically stable candidate for knee arthroscopy .
Inclusion criteria: All patients ( 18 to 50- year) candidate for arthroscopy under general anesthesia with Isoflurane or Propofol.
Exclusion criteria: Coagulation and bleeding disorders, history of nasal bleeding, drug abusers, blood transfusion during surgery, operation time more than 1.5 hour.
All patients undergo this procedure in an operation room with stable temperature (21-23 C).All liquids even irrigation serums should have a same temperature as the operation room. Induction and premedication drugs in both groups are similar. 20 patients with Isoflorane and 20 ones with Propofol will be anesthetised. The body temperature evaluates every 10 minutes with tympanic thermometer from intubation till extubation. Peripheral body temperature also measures by oral or axillary thermometer.systolic and diastolic Blood pressure and post anesthesia shivering assess in both groups. No warmer uses during operation. Collected data will be analysed.
General information
Acronym
ceipbtka
IRCT registration information
IRCT registration number:IRCT2012090410741N1
Registration date:2012-12-23, 1391/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-23, 1391/10/03
Registrant information
Name
Minoo Ghahraman
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 5814
Email address
m_ghahraman@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effects of Isoflurane and Propofol on body temperature changes during knee arthroscopy surgery
Public title
Comparing effects of Isoflurane and propofol on body temperature changes during knee arthroscopy surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All patients (18 to 50 years) candidate for knee arthroscopy under general anesthesia. Exclusion criteria: Coagulation and bleeding disorders; history of nasal bleeding, drug abusers; blood transfusion during surgery; endocrine disorders for example thyroid disease, kidney disease, hepatitis, high blood pressure, psychiateric disorders and history of allergy to propofol or narcotics; operation time more than 1.5 hour; hemodynamic instability during anesthesia.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethic Committee of Kerman University of Medical Sciences
Street address
Joomhoori blvd.
City
Kerman
Postal code
Approval date
2010-08-10, 1389/05/19
Ethics committee reference number
KA/91/105
Health conditions studied
1
Description of health condition studied
Knee Arthroscopy for treatment and diagnosis of knee ligaments tearing
ICD-10 code
M65-M68
ICD-10 code description
Disorders of synovium and tendon
Primary outcomes
1
Description
core body temprature
Timepoint
every 10 minuts during anesthesia and after extubation
Method of measurement
Degree celsius by tympanic thermometer
Secondary outcomes
1
Description
Post operative shivering
Timepoint
from extubation till departuring of recovery room every 10 minuts
Method of measurement
classification of shivering
2
Description
blood pressure
Timepoint
every 10 minuts at the time of taking core body temprature
Method of measurement
electronic blood pressure monitoring
3
Description
peripheral body temperature
Timepoint
every 10 minuts at the time of taking core body temprature
Method of measurement
oral thermometer
Intervention groups
1
Description
In group 1 Isoflurane (MAC;0.8-1.2); Premedication and induction medicines in both groups are similar, including Midazolam (2mg), Fentanyl ( 2µgr/kg ) for premedication and STP 5mg/kg - 0/5mg/kg/ Atracurium for induction. N2O%50 is administered in both groups.
Category
Treatment - Drugs
2
Description
In group 2 Propofol (200mg/kg/min); Premedication and induction medicines in both groups are similar, including Midazolam (2mg), Fentanyl ( 2µgr/kg ) for premedication and STP 5mg/kg - 0/5mg/kg/ Atracurium for induction. N2O%50 is administered in both groups.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Dr Mino Ghahraman
Street address
Farabi blvd.
City
Kerman
2
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Mohamadhassan Askari
Street address
Farabi blvd.
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman Univesity of Medical Sciences
Full name of responsible person
Research Deparment, Faranak khezri
Street address
Tahmasbabad cross
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman Univesity 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
Kerman Univesity of Medical Sciences
Full name of responsible person
Mohamadhassan Asskari
Position
Anesthesia Resident
Other areas of specialty/work
Street address
Shfa hospital, Farabi blvd.
City
Kerman
Postal code
7618751151
Phone
+98 34 1211 5806
Fax
Email
askarimohamadhasan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Minoo Ghahraman
Position
Assisstan Professor of Anesthesiology
Other areas of specialty/work
Street address
Shafa Hospital, Farabi blvd.
City
Kerman
Postal code
7618751151
Phone
+98 34 1211 5806
Fax
+98 34 1211 5806
Email
M_GHAHRAMAN@KMU.AC.IR
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohamadhassan Asskari
Position
Anesthesia Resident
Other areas of specialty/work
Street address
Shfa hospital, Farabi blvd.
City
Kerman
Postal code
7618751151
Phone
+98 34 1211 5806
Fax
+98 34 1211 5806
Email
askarimohamadhasan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)