Comparing tourniquet pressures during lower extremity surgery
Evaluation of Ischemia and Reperfusion Interval With Neuromonitorization in Tourniquet Application
NA · Istanbul University · NCT05926154
This study is testing whether using different pressures for tourniquets during lower leg surgeries affects nerve function and muscle health in patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Istanbul University (other) |
| Locations | 1 site (Istanbul, Fatih-Topkapı) |
| Trial ID | NCT05926154 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of two different tourniquet pressures on neuromonitoring and quadriceps muscle atrophy during lower extremity surgeries. Participants will be randomized into two groups receiving either limb occlusion pressure +50 mmHg or +100 mmHg. The study will assess neurophysiological effects, quadriceps tendon thickness, thigh circumference, and other parameters preoperatively and at follow-up intervals of 1 day, 1 week, and 1 month post-surgery. The goal is to determine the optimal reperfusion interval and the impact of tourniquet pressure on muscle denervation.
Who should consider this trial
Good fit: Ideal candidates are individuals scheduled for foot and ankle surgeries without significant comorbidities.
Not a fit: Patients with a history of previous foot or ankle surgeries, diabetes, or peripheral vascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced muscle atrophy in patients undergoing lower extremity surgeries.
How similar studies have performed: While similar studies have explored tourniquet pressures, this specific approach to neuromonitorization and its effects on quadriceps muscle atrophy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Istanbul, Fatih-Topkapı
- Department of Orthopaedics and Traumatology, Istanbul University, Istanbul, Turkey — Istanbul, Fatih-Topkapı, Turkey (RECRUITING)
Study contacts
- Study coordinator: Ahmet Muçteba YILDIRIM, Asistant Dr
- Email: ahmet.yildirim.93@istanbul.edu.tr
- Phone: 090 534 303 8472
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Quadriceps Muscle Atrophy, Tourniquet, EMG