Effect of Cafedrine/Theodrenaline and Urapidil on Cerebral Oxygenation

Cerebral Ischemia Clinical Trial

— NIRSMED  

Official title:

Effect of Cafedrine/Theodrenaline and Urapidil During Carotid Endarterectomy on Cerebral Oxygenation Measured by Near Infrared Spectroscopy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01311414
• Other study ID #: Fudickar6
• Status: Withdrawn
• Phase: N/A
• First received: March 7, 2011
• Last updated: May 21, 2014

Study information

• Verified date: May 2014
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for carotid endarterectomy

Exclusion Criteria:

• Cerebral disease

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction
• Cerebral Ischemia

Intervention

Drug:
• cafedrine/theodrenaline, urapidil
Increasing blood pressure using cafedrine/theodrenalin and decreasing blood pressure using urapidil during carotid endarterectomy.

Locations

Country	Name	City	State
Germany	University Hospital Schleswig-Holstein, Campus Kiel	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral oxygenation	Outcome measure is change of cerebral oxygenation measured by near-infrared spectroscopy from values at baseline (arterial blood pressure in normal range) to values three minutes after increasing systolic blood pressure above 160 mmHg by intravenous injection of cafedrin/theodrenalin as needed (0,5 - 1 ml).	1 hour	No