Evaluation of Ischemia and Reperfusion Interval With Neuromonitorization in Tourniquet Application
NCT ID: NCT05926154
Last Updated: 2023-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2023-01-01
2024-01-31
Brief Summary
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* What are the perioperative neurophysiological effects of ischemia and compression in the tissue under the tourniquet?
* Are the effects of two different tourniquet pressures on neuromonitoring significantly different?
* Can the ideal time of the reperfusion interval be evaluated by neuromonitoring?
* Are the effects of two different tourniquet pressures on the quadriceps denervation significantly different from each other? Participants meeting the inclusion criteria will be evaluated for parameters to be used preoperatively. It will be evaluated in the 1st day, 1st week and 1-month follow-ups in the postoperative period.
The investigators will compare two different tourniquet pressure ( Limb occlusion pressure +50 mmHg / + 100 mmHg) to see if it will be evaluated whether there is a significant difference in terms of quadriceps denervation, vas scores, total blood estimate volume loss, intraoperative MEP decrease, and recovery times, quadriceps tendon thickness, thigh circumfrences.
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Detailed Description
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Participants who met the inclusion and exclusion criteria were randomized in terms of tourniquet pressure to be applied and divided into two groups. It was planned to evaluate quadriceps tendon thickness by USG and MRI, thigh circumference, VAS scores, CBC, and CK in blood samples in the preoperative period of all patients. It was planned to obtain parameters related to MEP by using intraoperative neuromonitorization during the surgery. In the postoperative period, all parameters that were evaluated preoperatively on the 1st day, 1st week, and 1st month were re-evaluated. Finally, EMG evaluation was planned for 1 month.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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LOP + 50 mmHg
As a result of randomization, the surgical tourniquet pressure is 50 mmHg higher than the limb occlusion pressure. Limb occlusion pressure is calculated using the formulation by Graham: LOP = \[(Systolic Pressure - Diastolic Pressure)× (Limb Diameter) / 3 Cuff Width)\] + Diastolic Pressure
Surgical tourniquet pressure selection
Limb occlusion pressure is calculated using the formulation by Graham: LOP = \[(Systolic Pressure - Diastolic Pressure)× (Limb Diameter) / 3 Cuff Width)\] + Diastolic Pressure. One group is LOP + 50 mm Hg and other one is LOP + 100 mmHg
LOP + 100 mmHg
As a result of randomization, the surgical tourniquet pressure is 100 mmHg higher than the limb occlusion pressure. Limb occlusion pressure is calculated using the formulation by Graham: LOP = \[(Systolic Pressure - Diastolic Pressure)× (Limb Diameter) / 3 Cuff Width)\] + Diastolic Pressure
Surgical tourniquet pressure selection
Limb occlusion pressure is calculated using the formulation by Graham: LOP = \[(Systolic Pressure - Diastolic Pressure)× (Limb Diameter) / 3 Cuff Width)\] + Diastolic Pressure. One group is LOP + 50 mm Hg and other one is LOP + 100 mmHg
Interventions
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Surgical tourniquet pressure selection
Limb occlusion pressure is calculated using the formulation by Graham: LOP = \[(Systolic Pressure - Diastolic Pressure)× (Limb Diameter) / 3 Cuff Width)\] + Diastolic Pressure. One group is LOP + 50 mm Hg and other one is LOP + 100 mmHg
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Having a history of previous knee surgery or spinal surgery,
* Diagnosis of diabetes mellitus,
* Having a known diagnosis of a disease affecting the peripheral nervous system (peripheral neuropathy, previous spinal surgery, stroke, etc.),
* Having a diagnosis of a disease affecting the known peripheral vascular system (Peripheral vascular disease, calcified popliteal artery, peripheral arterial bypass surgery, vasculitis, advanced chronic venous insufficiency),
* Having a disease that affects the ideal tourniquet application (Chronic Lymphedema, BMI\>35, Stage 3 and above chronic renal failure, uncontrollable hypertension),
* Having been diagnosed with a known coagulation disorder,
* History of pulmonary embolism or deep vein thrombosis.
* ASA score above 3
* Surgery time to be less than 80 minutes
18 Years
65 Years
ALL
No
Sponsors
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Istanbul University
OTHER
Responsible Party
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AHMET MUCTEBA YILDIRIM
Principal Investigator, MD
Principal Investigators
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Serkan BAYRAM, Ass. Prof.
Role: STUDY_DIRECTOR
Istanbul University Medicine Faculty Orthoapedic and Traumatology Department
Locations
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Department of Orthopaedics and Traumatology, Istanbul University, Istanbul, Turkey
Istanbul, Fatih-Topkapı, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Yildirim AM, Bayram S, Kizilkurt T, Canbolat N, Baslo MB, Asik M. Low tourniquet pressure has less impact on lower extremity nerve innervation: comparison of different tourniquet pressures used with intraoperative neuromonitoring with a randomized controlled study. J Orthop Surg Res. 2024 Oct 23;19(1):684. doi: 10.1186/s13018-024-05176-y.
Other Identifiers
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Low Extremity neuromonitoring
Identifier Type: -
Identifier Source: org_study_id
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