Comparison of the effect of Spinal and General Anesthesia on Serum Lipid Peroxides and Total Antioxidant Capacity in Diabetic Patients with Lower Limb Amputation Surgery
Propose: Comparison of spinal and general anesthesia on serum Lipid Peroxides and total antioxidant capacity in Diabetic patients with lower limb amputation surgery. Design and criteria: This study is prospective, randomized and clinical trial. In this study were randomly divided into three groups. In group 1, with general anesthesia (n = 20), pretreatment with midazolam 04/0 mg kg, fentanyl 3 micrograms per kilogram, and the induction of anesthesia with propofol 2 mg kg, were used. In group 2 (n=20) with spinal anesthesia, 3 ml Bupivacaine 0.5% was injected into the subarachnoid space of the spinal canal between the third and fourth lumbar space or between the fifth lumbar and first sacral space of the spinal column. In third group with 23 healthy volunteers (age and gender-matched) were recruited to have a control group for a better interpretation of laboratory data in our patients. Inclusion criteria: Diabetic patient with diabetic foot who were candidate for lower limb amputation. Exclusion criteria: Lack of consent to participate in the study; Antioxidant supplements such as vitamin C; Neuraxial uplink block is prohibited; End-stage renal disease. Primary outcome: Serum total antioxidant capacity and Level of Serum Lipid Peroxidation. Time of measurement: Before induction, 1 hour after surgery. Intervention group: group 1 and 2 candidates for amputation under general and spinal anesthesia. Control group: 23 healthy volunteers were recruited to have a control group for a better interpretation of laboratory data in our patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402208384N3
Registration date:2014-08-01, 1393/05/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-01, 1393/05/10
Registrant information
Name
Arash Peivandi Yazdi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 5209
Email address
peivandia@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Science
Expected recruitment start date
2012-11-30, 1391/09/10
Expected recruitment end date
2013-08-01, 1392/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Spinal and General Anesthesia on Serum Lipid Peroxides and Total Antioxidant Capacity in Diabetic Patients with Lower Limb Amputation Surgery
Public title
Comparison of general and spinal anesthesia on the body's defense systems in diabetic patients
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Diabetic patient with diabetic foot who were candidate for lower limb amputation.
Exclusion criteria: Lack of consent to participate in the study; Antioxidant supplements such as vitamin C; Neuraxial uplink block is prohibited; End-stage renal disease.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
63
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
Ethics Committee of Mashhad University of Medical sciences
Intervention group 1 : In group 1 with general anesthesia (n = 20), pretreatment with midazolam 04/0 mg kg, fentanyl 3 micrograms per kilogram, and the induction of anesthesia with propofol 2 mg kg, were used
Category
Treatment - Drugs
2
Description
Intervention group 2 : For patients in SA group, 3 ml Bupivacaine 0.5% was injected into the subarachnoid space of the spinal canal between the third and fourth lumbar space or between the fifth lumbar and first sacral space of the spinal column
Category
Treatment - Drugs
3
Description
Control group: 23 healthy volunteers (age and gender-matched) were recruited to have a control group for a better interpretation of laboratory data in our patients.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Arash Peivandi
Street address
Imam Reza Hospital, Ibne Sina street, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Science
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreishi apartment, Daneshgah street, Mashhad,
City
Mashhad
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, Mashhad University of Medical Science
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
Mashhad University of Medical Sciences
Full name of responsible person
Arash Peivandi Yazdi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1852 5209
Fax
Email
peivandia@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arash Peivandi Yazdi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1852 5209
Fax
Email
peivandia@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arash Peivandi Yazdi
Position
Assistant professor
Other areas of specialty/work
Street address
Depatment of anesthesia, Imam Reza hospital, Ibne Sina Street,
City
Mashhad
Postal code
Phone
+98 51 1852 5209
Fax
+98 51 1852 5209
Email
peivandia@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)