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NCT Number: NCT03389607

The Role of SCUBE-1 in Ischemia-reperfusion Injury

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

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Key information

Conditions

Gonarthrosis Arthritis Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Joint Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

university of health siences diskapi yildirim beyazit T&R hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

spinal anesthesia

Diagnostic Test

before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation SCUBE-1, MDA and TAC will measured from plasma

Primary outcomes

  1. SCUBE-1

    Time frame: before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation

    mean level of SCUBE-1

Secondary outcomes

  1. malondialdehyde (MDA)

    Time frame: before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation

    mean level of MDA

  2. total antioxidant capacity

    Time frame: before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation

    mean level of total antioxidant capacity (TAC)

Sponsors and collaborators

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Other Gov

Registry information

Official study title

The Role of SCUBE-1 in Ischemia-reperfusion Injury in Patients With Knee Prosthesis

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 3, 2018
Registry last updated
Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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