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Effect of Cafedrine/Theodrenaline and Urapidil on Cerebral Oxygenation

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01311414
Acronym
NIRSMED
Enrollment
0
Registered
2011-03-09
Start date
Unknown
Completion date
Unknown
Last updated
2014-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Ischemia

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.

Interventions

DRUGcafedrine/theodrenaline, urapidil

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

Sponsors

University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients scheduled for carotid endarterectomy

Exclusion criteria

* Cerebral disease

Design outcomes

Primary

MeasureTime frameDescription
Cerebral oxygenation1 hourOutcome 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).

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026