Clinical Trials Directory

Trials / Unknown

UnknownNCT01451294

Effect of Blood Pressure on rSO2 in Carotid Endarterectomy (CEA)

The Effect of Phenylephrine Versus Ephedrine on Cerebral Perfusion During Carotid Endarterectomy

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
G.J. de Borst · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

Carotid endarterectomy (CEA) is the recommended treatment for symptomatic high degree stenosis of the internal carotid artery (ICA). ICA obstruction is often associated with an impaired cerebral autoregulation, implicating that cerebral perfusion pressure becomes dependent on systemic blood pressure. Therefore, to maintain cerebral perfusion pressure in this type of patients intraoperative hypotension needs to be avoided. Different short-acting agents such as phenylephrine, (a drug with vasoconstrictive properties), or ephedrine (a drug with vasoconstrictive properties combined with an increase in heart rate) can be used to correct intra-operative hypotension. In healthy subjects these agents affect the cerebral perfusion differently despite an identical effect on the systemic blood pressure. Cerebral perfusion decreases after phenylephrine administration while it is preserved after the use of ephedrine. The optimal agent for correcting hypotension in CEA patients, and thus in a situation of an impaired cerebral autoregulation, is unknown. Therefore, the investigators propose to perform a prospective study observing the effect of phenylephrine and ephedrine on cerebral perfusion to make a recommendation regarding the use of either phenylephrine or ephedrine during CEA.

Conditions

Interventions

TypeNameDescription
DRUGAdministration of phenylephrinePhenylephrine: 50-100µg
DRUGAdministration of ephedrineEphedrine: 5- 10 mg

Timeline

Start date
2011-11-01
Primary completion
2012-03-01
Completion
2012-03-01
First posted
2011-10-13
Last updated
2011-10-13

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT01451294. Inclusion in this directory is not an endorsement.