Evaluation of Ischemia and Reperfusion Interval With Neuromonitorization in Tourniquet Application

NCT05926154 | Unknown

• 1 other identifier: Low Extremity neuromonitoring
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Quadriceps Muscle Atrophy; Tourniquet; EMG

Outcome Measures

Primary Outcomes (2)

• MEP 50% reduction in intraoperative neuromonitorization

  Time with more than 50% reduction in perioperative MEP will be compared in groups in which two different tourniquet pressures were applied.

  Intraoperative

• MEP full recovery intraoperative neuromonitorization

  Time with full recovery in perioperative MEP will be compared in groups in which two different tourniquet pressures were applied.

  Intraoperative

Secondary Outcomes (7)

• Quadriceps Tendon Thickness-USG

  Preoperative, Postoperative 1st day and 4th week will be evaluated

• Quadriceps Tendon Thickness-MRI

  Preoperative, Postoperative third month

• Thigh Diameter

  Preoperative, Postoperative 1st day, first week and 4th week will be evaluated

• Total Blood Estimate Volume Loss

  Preoperative, Postoperative 1st day

• CK levels

  Preoperative, Postoperative 1st day, Postoperative 1 st month

Study Arms (2)

LOP + 50 mmHg

EXPERIMENTAL

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

Procedure: Surgical tourniquet pressure selection

LOP + 100 mmHg

EXPERIMENTAL

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

Procedure: Surgical tourniquet pressure selection

Interventions

Surgical tourniquet pressure selection PROCEDURE

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; LOP + 50 mmHg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Operation planning in the foot and ankle area

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Department of Orthopaedics and Traumatology, Istanbul University, Istanbul, Turkey

Istanbul, Fatih-Topkapı, 34080, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 39444003 DERIVED

Study Officials

• Serkan BAYRAM, Ass. Prof.

  Istanbul University Medicine Faculty Orthoapedic and Traumatology Department

  STUDY DIRECTOR

Central Study Contacts

Ahmet Muçteba YILDIRIM, Asistant Dr

CONTACT

090 534 303 8472; ahmet.yildirim.93@istanbul.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: July 3, 2023
• Study Start: January 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: January 1, 2024
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

TU (1)