Effect of Cafedrine/Theodrenaline and Urapidil on Cerebral Oxygenation

Not Applicable

Withdrawn

• Conditions: Cerebral Ischemia
• Interventions: Drug: cafedrine/theodrenaline, urapidil

• Registration Number: NCT01311414
• Lead Sponsor: University Hospital Schleswig-Holstein

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-07
• Study First Submitted QC: 2011-03-08
• Study First Posted: 2011-03-09
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-21
• Last Update Posted: 2014-05-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients scheduled for carotid endarterectomy

Exclusion Criteria

• Cerebral disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cafedrine/theodrenalin	cafedrine/theodrenaline, urapidil	-

Primary Outcome Measures

Name	Time	Method
Cerebral oxygenation	1 hour	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).

Trial Locations

Locations (1)

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