NCT05926154

Evaluation of Ischemia and Reperfusion Interval With Neuromonitorization in Tourniquet Application

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Istanbul University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Quadriceps Muscle Atrophy
• Tourniquet
• EMG

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-11-01
• Completion: 2024-01-01
• First posted: 2023-07-03
• Last updated: 2023-07-03

Locations

1 site across 1 country: Turkey (Türkiye)