Evaluation of Ischemia and Reperfusion Interval With Neuromonitorization in Tourniquet Application

Istanbul University

Status: Enrolling

Conditions: Tourniquet; Quadriceps Muscle Atrophy; EMG

Treatments: Procedure: Surgical tourniquet pressure selection

Study type: Interventional

Funder types: Other

Identifiers

NCT05926154

Low Extremity neuromonitoring

Details and patient eligibility

About

The goal of this clinical trial is to compare two differential tourniquet pressure in lower extremity surgery cases. The main questions it aims to answer are:

• 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.

Full description

As a result of the power analysis for this study, the number of samples was determined as 24. The study was started after the approval of the ethics committee.

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Operation planning in the foot and ankle area

Exclusion criteria

• Having a history of previous foot and ankle surgery,
• 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

LOP + 50 mmHg

Experimental group

Description:

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

Treatment:

Procedure: Surgical tourniquet pressure selection

LOP + 100 mmHg

Experimental group

Description:

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

Treatment:

Procedure: Surgical tourniquet pressure selection