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

NCT01451294 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-10-13

No results posted yet for this study

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

  • Intra-operative Hypotension
  • Carotid Stenosis

Interventions

DRUG

Administration of phenylephrine

Phenylephrine: 50-100µg

DRUG

Administration of ephedrine

Ephedrine: 5- 10 mg

Sponsors & Collaborators

  • G.J. de Borst

    lead OTHER

Principal Investigators

  • Gert Jan de Borst, MD, PhD · UMC Utrecht, The Netherlands

  • Claire Pennekamp, MD · UMC Utrecht, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01451294 on ClinicalTrials.gov