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

This study has been withdrawn prior to enrollment.
(The study was suspended due to organizational problems)
Sponsor:
Information provided by (Responsible Party):
Axel Fudickar, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01311414
First received: March 7, 2011
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Cerebral Ischemia
Drug: cafedrine/theodrenaline, urapidil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Cafedrine/Theodrenaline and Urapidil During Carotid Endarterectomy on Cerebral Oxygenation Measured by Near Infrared Spectroscopy

Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • Cerebral oxygenation [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    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).


Enrollment: 0
Arms Assigned Interventions
Experimental: cafedrine/theodrenalin Drug: cafedrine/theodrenaline, urapidil
Increasing blood pressure using cafedrine/theodrenalin and decreasing blood pressure using urapidil during carotid endarterectomy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for carotid endarterectomy

Exclusion Criteria:

  • Cerebral disease
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01311414

Locations
Germany
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, Germany, 24105
Sponsors and Collaborators
University of Schleswig-Holstein
  More Information

No publications provided

Responsible Party: Axel Fudickar, Dr. med., University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT01311414     History of Changes
Other Study ID Numbers: Fudickar6
Study First Received: March 7, 2011
Last Updated: May 21, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Cerebral Infarction
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Stroke
Vascular Diseases
Cafedrine
Norepinephrine
Theodrenaline
Theophylline
Urapidil
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Agonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Anti-Asthmatic Agents
Antihypertensive Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 23, 2014