Clinical trial NCT03389607: The Role of SCUBE-1 in Ischemia-reperfusion Injury
Official title: The Role of SCUBE-1 in Ischemia-reperfusion Injury in Patients With Knee Prosthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gonarthrosis
Diabetes
Keywords: SCUBE-1
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-01-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the patients who will go to surgery for gonarthrosis disease

Brief summary: One consequence of tissue damage caused by tourniquet is ischemia-reperfusion injury. Short-term ischemia leads to vasodilatation and reactive hyperemia resulting in post-ischemic reperfusion microcirculation failure and tissue edema that extends from 30 minutes to 4 hours.

SCUBE-1 is a newly defined cell surface molecule. It emerges from many developing cells, including endothelium and platelets. Immunohistochemical demonstration of subendothelial matrix deposition in atherosclerosis in humans. We did not find any study that showed the post-ischemic regression of scube 1, which was shown to be significantly higher in ischemic events in the literature.

in this study is aimed to investigate the location / sensitivity of SCUBE-1 in diabetics and nondiabetics after application of regional anesthesia for ischemia-reperfusion injury induced by tourniquet application in knee prosthesis attempts in our aimed patients and compare this with other total antioxidant status (TAS) and MDA of ischemia-reperfusion parameters

Detailed description: After being taken to the operation room, the patient will be divided into two groups as group D (diabetic) and group K (control) by standardized anesthesia monitoring with 5-lead electrocardiogram (ECG), peripheral oxygen saturation (SpO2) and noninvasive blood pressure measurements.

In both groups, spinal anesthesia will be applied in a lateral decubitus position using a 22 gauge Quincke spinal needle from the interspinal space as 0.5% heavy marcaine 10-12.5 mg 1 min. Atropine 0.5 mg and ephedrine 5 mg should be administered if bradycardia develops in both groups. The disease tourniquet will be applied after induction, in accordance with the literature, to be above 150 mmHg of the systolic blood pressure.

Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus
* knee replacement surgery
* using a pneumatic tourniquet

Exclusion Criteria:

* coronary artery disease
* renal disorders
* cognitive disorders
* bleeding diathesis
* who have passed general anesthesia
* anti-inflammatory drugs treatment
* abnormal HbA1c values

Primary outcomes:
measure: SCUBE-1
timeFrame: before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation
Secondary outcomes:
measure: malondialdehyde (MDA)
timeFrame: before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation
measure: total antioxidant capacity
timeFrame: before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: university of health siences diskapi yildirim beyazit T&R hospital
Study officials:
References: