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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01451294
Enrollment
40
Registered
2011-10-13
Start date
2011-11-30
Completion date
2012-03-31
Last updated
2011-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Stenosis, Intra-operative Hypotension

Keywords

Cerebral autoregulation

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.

Interventions

Phenylephrine: 50-100µg

Ephedrine: 5- 10 mg

Sponsors

G.J. de Borst
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. All patients undergoing CEA in the University Medical Centre Utrecht and having an appropriate temporal bone window for reliable perioperative TCD monitoring could be included. 2. All patients must have given written informed consent.

Exclusion criteria

1. Not having a temporal bone window appropriate for TCD measurement 2. Not willing to give informed consent. 3. If the effect on BP of the given agents is insufficient (if relative hypotension persists five minutes after administration).

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Blood velocity (Vmca) measured using transcranial DopplerWithin 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.

Countries

Netherlands

Contacts

Primary ContactGert Jan de Borst, MD, PhD
g.j.deborst-2@umcutrecht.nl+31 8875556965
Backup ContactClaire Pennekamp, MD
c.w.a.pennekamp-2@umcutrecht.nl+31 8875556965

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026