Effect of Blood Pressure on rSO2 in Carotid Endarterectomy (CEA)
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|ClinicalTrials.gov Identifier: NCT01451294|
Recruitment Status : Unknown
Verified October 2011 by G.J. de Borst, UMC Utrecht.
Recruitment status was: Not yet recruiting
First Posted : October 13, 2011
Last Update Posted : October 13, 2011
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.
|Condition or disease||Intervention/treatment|
|Intra-operative Hypotension Carotid Stenosis||Drug: Administration of phenylephrine Drug: Administration of ephedrine|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effect of Phenylephrine Versus Ephedrine on Cerebral Perfusion During Carotid Endarterectomy|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||March 2012|
|Estimated Study Completion Date :||March 2012|
|Active Comparator: Ephedrine||
Drug: Administration of ephedrine
Ephedrine: 5- 10 mg
|Active Comparator: Phenylephrine||
Drug: Administration of phenylephrine
- cerebral perfusion (rSO2) measured using Near Infrared Spectroscopy [ Time Frame: (day 1) Monitoring will take place only on the day of operation. No further follow-up. Timeframe is 1 day. ]A continuous measurement during surgery will be performed. However for further analysis only a short time frame will be used.
- Blood velocity (Vmca) measured using transcranial Doppler [ Time Frame: Within 18 months in consecutive patients undergoing carotid endarterectomy. Endpoints will only be assessed during actual surgery (approximately 90 minutes in total) no data will be assessed during follow-up. ]A continuous measurement during surgery will be performed. However for further analysis only a short time frame will be used.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01451294
|Contact: Gert Jan de Borst, MD, PhD||+31 firstname.lastname@example.org|
|Contact: Claire Pennekamp, MD||+31 email@example.com|
|University Medical Center Utrecht||Not yet recruiting|
|Utrecht, Netherlands, 3584 CX|
|Contact: Gert Jan de Borst, MD, PhD +31 8875556965 firstname.lastname@example.org|
|Study Director:||Gert Jan de Borst, MD, PhD||UMC Utrecht, The Netherlands|
|Principal Investigator:||Claire Pennekamp, MD||UMC Utrecht, The Netherlands|