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

Not Applicable

• Conditions: Intra-operative Hypotension; Carotid Stenosis
• Interventions: Drug: Administration of ephedrine; Drug: Administration of phenylephrine

• Registration Number: NCT01451294
• Lead Sponsor: G.J. de Borst

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-22
• Status Verified: 2011-10
• Study First Submitted QC: 2011-10-12
• Last Update Submitted: 2011-10-12
• Study First Posted: 2011-10-13
• Last Update Posted: 2011-10-13
• Study Start: 2011-11
• Primary Completion: 2012-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ephedrine	Administration of ephedrine	-
Phenylephrine	Administration of phenylephrine	-

Primary Outcome Measures

Name	Time	Method
cerebral perfusion (rSO2) measured using Near Infrared Spectroscopy	(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.

Secondary Outcome Measures

Name	Time	Method
Blood velocity (Vmca) measured using transcranial Doppler	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.

Trial Locations

Locations (1)

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands