The main objective of this study is comparing Hs-CRP level in two method of anesthesia in patients undergoing lower extremity surgery. This is a clinical trial on 60 male patients aged 40 to 60 and BMI between 20 to 25 who are candidate for lower extremity surgery (plaque removal).
Inclusion criteria: lower extremity surgery; age 40 to 60 year; male sex.
Exclusion criteria: polymyositis; neurological disorders; hepatic failure; diabetes (DM); malignancies; pulmonary hypertension; serum Cr above 2 mg/dl; platelet under 150,000; INR under 1.1; steroids consumption within last 6 months; multiple trauma patients.
The patients are divided into 2 groups randomly by means of draw. In group A general anesthesia and in group B spinal anesthesia is performed. Before fluid administration, a blood sample is taken for measuring Hs-CRP. During anesthesia they are monitored and their blood pressure is recorded every 10 minutes. In recovery room and 30 minutes after arrival, another blood sample is sent for analysis and third sample will be taken the next day in the morning.
Finally the effects of these methods on Hs-CRP level will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202067488N2
Registration date:2015-06-01, 1394/03/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-01, 1394/03/11
Registrant information
Name
Mohammadali Haghbin
Name of organization / entity
Kerman University of MedicalSciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 5814
Email address
m.a.haghbin@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman University of Medical sciences
Expected recruitment start date
2015-01-01, 1393/10/11
Expected recruitment end date
2015-06-01, 1394/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effects of two different methods of anesthesia on Hs-CRP blood level in patients undergoing lower extremity surgery
Public title
comparing the blood level of acute phase protein (Hs-CRP) in two methods of anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: lower extremity surgery; age 40 to 60 year; male sex.
Exclusion criteria: polymyositis; neurologic disorders; hepatic failure; diabetes (DM); malignancies; pulmonary hypertension; serum Cr above 2 mg/dl; platelet under 150,000; INR under 1.1; steroids consumption within last 6 months; multiple trauma patients.
Age
From 40 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Kerman University of Medical Sciences
Street address
Shafa Square, Jomhoori Boulevard
City
Kerman
Postal code
Approval date
2015-01-21, 1393/11/01
Ethics committee reference number
k/93/536
Health conditions studied
1
Description of health condition studied
anaesthesia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia
Primary outcomes
1
Description
Hs-CRP blood level
Timepoint
before induction of anaesthesia, half an hour after admission to recovery room and next day
Method of measurement
blood anlysis
Secondary outcomes
1
Description
blood pressure
Timepoint
every 10 minutes
Method of measurement
automatic monitoring device
Intervention groups
1
Description
Performing lower extremity surgery under general anesthesia
Category
Treatment - Surgery
2
Description
Performing lower extremity surgery under spinal anesthesia
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Mohamad Ali Haghbin
Street address
Farabi Street, Shafa hospital
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hassani
Street address
Tahmasbabad Square, Ebnesina Street
City
Kerman
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, Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Zohreh Morshedizad
Position
Assistant of Anesthesiology
Other areas of specialty/work
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Postal code
Phone
+98 34 3223 5011
Fax
Email
javakrd34@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohamadali Haghbin
Position
anesthesiolgist
Other areas of specialty/work
Street address
Shafa Hospirtal, Farabi Street
City
Kerman
Postal code
Phone
+98 34 3211 5814
Fax
Email
m.a.haghbin@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zohreh Morshedizad
Position
Assistant of Anesthesiology
Other areas of specialty/work
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Postal code
Phone
+98 34 3223 5011
Fax
Email
javakrd34@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)