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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
Information provided by (Responsible Party):
G.J. de Borst, UMC Utrecht

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.

Condition or disease Intervention/treatment Phase
Intra-operative Hypotension Carotid Stenosis Drug: Administration of phenylephrine Drug: Administration of ephedrine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Active Comparator: Ephedrine Drug: Administration of ephedrine
Ephedrine: 5- 10 mg

Active Comparator: Phenylephrine Drug: Administration of phenylephrine
Phenylephrine: 50-100µg

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts 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).

Information from the National Library of Medicine

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

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Contact: Gert Jan de Borst, MD, PhD +31 8875556965 g.j.deborst-2@umcutrecht.nl
Contact: Claire Pennekamp, MD +31 8875556965 c.w.a.pennekamp-2@umcutrecht.nl

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University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Contact: Gert Jan de Borst, MD, PhD    +31 8875556965    g.j.deborst-2@umcutrecht.nl   
Sponsors and Collaborators
G.J. de Borst
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Study Director: Gert Jan de Borst, MD, PhD UMC Utrecht, The Netherlands
Principal Investigator: Claire Pennekamp, MD UMC Utrecht, The Netherlands
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: G.J. de Borst, Vascular surgeon; Head of cerebrovascular surgical programme., UMC Utrecht
ClinicalTrials.gov Identifier: NCT01451294    
Other Study ID Numbers: 11-195
First Posted: October 13, 2011    Key Record Dates
Last Update Posted: October 13, 2011
Last Verified: October 2011
Keywords provided by G.J. de Borst, UMC Utrecht:
Cerebral autoregulation
Additional relevant MeSH terms:
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Carotid Stenosis
Vascular Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Central Nervous System Stimulants