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Effect of Cafedrine/Theodrenaline and Urapidil on Cerebral Oxygenation (NIRSMED)

U

University Hospital Schleswig-Holstein (UKSH)

Status

Withdrawn

Conditions

Cerebral Ischemia

Treatments

Drug: cafedrine/theodrenaline, urapidil

Study type

Interventional

Funder types

Other

Identifiers

NCT01311414
Fudickar6

Details and patient eligibility

About

During clamping of one internal carotid artery for endarterectomy, blood flow through this vessel has to be compensated by collateral arteries including the contralateral internal artery and vertebral arteries. In 7 % of all patients undergoing carotid endarterectomy this collateral flow is not sufficient to maintain adequate cerebral perfusion during clamping and ischemic brain damage is likely to emerge. To maximize cerebral blood flow during clamping, increase of blood pressure is a common procedure and routine at our institution. Increasing blood pressure can be enabled by tapering a mixture of Cafedrine und Theodrenalin (Akrinor®) until the designated blood pressure is reached. After declamping, the blood pressure has to be reduced to normal values to avoid postoperative hyperperfusion syndrome. This is enabled by tapering urapidil until normal blood pressure is achieved.

It has been shown that cerebral oxygenation measured by near infrared spectroscopy is reduced by intravenous application of norepinephrine. Otherwise, intravenous nitroglycerine increases cerebral oxygenation during cardiopulmonary bypass. Hence, cafedrine/theodrenalin and urapidil may also have an effect on cerebral perfusion. In this prospective randomized study the effect of cafedrine/theodrenalin and urapidil on cerebral oxygenation measured by near infrared spectroscopy is investigated.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients scheduled for carotid endarterectomy

Exclusion criteria

  • Cerebral disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

cafedrine/theodrenalin
Experimental group
Treatment:
Drug: cafedrine/theodrenaline, urapidil

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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