Clinical trial NCT05926154: Evaluation of Ischemia and Reperfusion Interval With Neuromonitorization in Tourniquet Application
Official title: Evaluation of Ischemia and Reperfusion Interval With Neuromonitorization in Tourniquet Application
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quadriceps Muscle Atrophy
Tourniquet
EMG
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: MEP 50% reduction in intraoperative neuromonitorization
timeFrame: Intraoperative
measure: MEP full recovery intraoperative neuromonitorization
timeFrame: Intraoperative
Secondary outcomes:
measure: Quadriceps Tendon Thickness-USG
timeFrame: Preoperative, Postoperative 1st day and 4th week will be evaluated
measure: Quadriceps Tendon Thickness-MRI
timeFrame: Preoperative, Postoperative third month
measure: Thigh Diameter
timeFrame: Preoperative, Postoperative 1st day, first week and 4th week will be evaluated
measure: Total Blood Estimate Volume Loss
timeFrame: Preoperative, Postoperative 1st day
measure: CK levels
timeFrame: Preoperative, Postoperative 1st day, Postoperative 1 st month
measure: EMG
timeFrame: Postoperative 1 st month
measure: Surgical Area Pain
timeFrame: Preoperative, Postoperative 1st day, Postoperative 1 st month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Department of Orthopaedics and Traumatology, Istanbul University, Istanbul, Turkey
state: Fatih-Topkapı
Study officials:
affiliation: Istanbul University Medicine Faculty Orthoapedic and Traumatology Department
name: Serkan BAYRAM, Ass. Prof.
role: STUDY_DIRECTOR
References: