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
| Type | Name | Description |
|---|---|---|
| DRUG | Administration of phenylephrine | Phenylephrine: 50-100µg |
| DRUG | Administration of ephedrine | Ephedrine: 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.