Tissue Oxygenation of the Tibial Anterior Muscle After Clamping of the Femoral Artery

Not Applicable

Completed

• Conditions: Tissue Oxygen Saturation
• Interventions: Procedure: Sevoflurane preconditioning

• Registration Number: NCT02038062
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief Summary

Ischemic preconditioning is defined as protection from cell damage induced by prolonged ischemia by preceding cycles of short ischemia. Hence, ischemic preconditioning could reduce ischemic lesion during clamping a femoral artery for vascular surgery. In this prospective, randomized pilot study is investigated if clamping of the femoral artery leads to ischemia of the calf measurable by near-infrared spectroscopy. In addition to this, the effect of sevoflurane preconditioning on ischemia of the calf is measured.

Detailed Description

Ischemic preconditioning is performed by clamping of the femoral artery for five minutes in 40 patients. In 20 patients sevoflurane preconditioning is performed five minutes before ischemic preconditioning by inducing sevoflurane anesthesia for five minutes. Muscle tissue oxygenation is measured bilaterally in the anterior tibial muscle by near-infrared spectroscopy (INVOS, SOMANETICS, Troy, Michigan/ USA) during preconditioning and following ischemia.Clinically relevant ischemia was defined as a decrease of tissue oxygen saturation to 95 % of baseline.

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-15
• Study First Posted: 2014-01-16
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-27
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

vascular surgery with clamping of a femoral artery. -

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane	Sevoflurane preconditioning	Sevoflurane Preconditioning

Primary Outcome Measures

Name	Time	Method
Decrease of tissue oxygen saturation below 95 % of baseline	4 hours	Decrease of tissue oxygen saturation below 95 % of baseline

Trial Locations

Locations (1)

University Hospital Schleswig-Holstein, Campus Kiel; 🇩🇪 Kiel, Schleswig-Holstein, Germany