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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by UMC Utrecht.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
G.J. de Borst, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01451294
First received: September 22, 2011
Last updated: October 12, 2011
Last verified: October 2011
  Purpose

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 Intervention
Intra-operative Hypotension
Carotid Stenosis
Drug: Administration of phenylephrine
Drug: Administration of ephedrine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Phenylephrine Versus Ephedrine on Cerebral Perfusion During Carotid Endarterectomy

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    A continuous measurement during surgery will be performed. However for further analysis only a short time frame will be used.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    A continuous measurement during surgery will be performed. However for further analysis only a short time frame will be used.


Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ephedrine Drug: Administration of ephedrine
Ephedrine: 5- 10 mg
Active Comparator: Phenylephrine Drug: Administration of phenylephrine
Phenylephrine: 50-100µg

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451294

Contacts
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

Locations
Netherlands
University Medical Center Utrecht Not yet recruiting
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
Investigators
Study Director: Gert Jan de Borst, MD, PhD UMC Utrecht, The Netherlands
Principal Investigator: Claire Pennekamp, MD UMC Utrecht, The Netherlands
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: G.J. de Borst, Vascular surgeon; Head of cerebrovascular surgical programme., UMC Utrecht
ClinicalTrials.gov Identifier: NCT01451294     History of Changes
Other Study ID Numbers: 11-195
Study First Received: September 22, 2011
Last Updated: October 12, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
Cerebral autoregulation

Additional relevant MeSH terms:
Carotid Stenosis
Hypotension
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Ephedrine
Oxymetazoline
Phenylephrine
Pseudoephedrine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiotonic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Stimulants
Molecular Mechanisms of Pharmacological Action
Mydriatics
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2014