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Evaluation of Ischemia and Reperfusion Interval With Neuromonitorization in Tourniquet Application

NCT05926154 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-07-03

No results posted yet for this study

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

Interventions

PROCEDURE

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

Sponsors & Collaborators

  • Istanbul University

    lead OTHER

Principal Investigators

  • Serkan BAYRAM, Ass. Prof. · Istanbul University Medicine Faculty Orthoapedic and Traumatology Department

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-11-30
Completion
2024-01-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05926154 on ClinicalTrials.gov