Effect of Cafedrine/Theodrenaline and Urapidil on Cerebral Oxygenation

NCT ID: NCT01311414

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

Brief Summary

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.

Conditions

Cerebral Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

cafedrine/theodrenalin

Group Type: EXPERIMENTAL

cafedrine/theodrenaline, urapidil

Intervention Type: DRUG

Increasing blood pressure using cafedrine/theodrenalin and decreasing blood pressure using urapidil during carotid endarterectomy.

Interventions

cafedrine/theodrenaline, urapidil

Increasing blood pressure using cafedrine/theodrenalin and decreasing blood pressure using urapidil during carotid endarterectomy.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients scheduled for carotid endarterectomy

Exclusion Criteria

• Cerebral disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Axel Fudickar

Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, Germany

Countries

Germany

Other Identifiers

Fudickar6

Identifier Type: -

Identifier Source: org_study_id