Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT01451294
Status:
UNKNOWN
Last Update Posted:
2011-10-13
First Post:
2011-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Blood Pressure on rSO2 in Carotid Endarterectomy (CEA)
Sponsor:
G.J. de Borst
Organization:
Study Overview
Official Title:
The Effect of Phenylephrine Versus Ephedrine on Cerebral Perfusion During Carotid Endarterectomy
Status:
UNKNOWN
Status Verified Date:
2011-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: