Evaluation of Ischemia & Reperfusion Interval With Neuromonitorization in

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05926154
Study type	Interventional
Source	Istanbul University
Contact	Ahmet Muçteba YILDIRIM, Asistant Dr
Phone	090 534 303 8472
Email	ahmet.yildirim.93@istanbul.edu.tr
Status	Recruiting
Phase	N/A
Start date	January 1, 2023
Completion date	January 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluation of Ischemia and Reperfusion Interval With Neuromonitorization in Tourniquet Application

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms