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Tissue Oxygenation of the Tibial Anterior Muscle After Clamping of the Femoral Artery (NIRSFEM)

U

University Hospital Schleswig-Holstein (UKSH)

Status

Completed

Conditions

Tissue Oxygen Saturation

Treatments

Procedure: Sevoflurane preconditioning

Study type

Interventional

Funder types

Other

Identifiers

NCT02038062
Fudickar7

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:vascular surgery with clamping of a femoral artery. -

Exclusion Criteria:

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Sevoflurane
Experimental group
Description:
Sevoflurane Preconditioning
Treatment:
Procedure: Sevoflurane preconditioning
No Sevoflurane
No Intervention group
Description:
No Sevoflurane Preconditioning

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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