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

Information source: UMC Utrecht
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Intra-operative Hypotension; Carotid Stenosis

Intervention: Administration of phenylephrine (Drug); Administration of ephedrine (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: G.J. de Borst

Official(s) and/or principal investigator(s):
Gert Jan de Borst, MD, PhD, Study Director, Affiliation: UMC Utrecht, The Netherlands
Claire Pennekamp, MD, Principal Investigator, Affiliation: UMC Utrecht, The Netherlands

Overall contact:
Gert Jan de Borst, MD, PhD, Phone: +31 8875556965, Email: g.j.deborst-2@umcutrecht.nl

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: cerebral perfusion (rSO2) measured using Near Infrared Spectroscopy

Secondary outcome: Blood velocity (Vmca) measured using transcranial Doppler

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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).

Locations and Contacts

Gert Jan de Borst, MD, PhD, Phone: +31 8875556965, Email: g.j.deborst-2@umcutrecht.nl

University Medical Center Utrecht, Utrecht 3584 CX, Netherlands; Not yet recruiting
Gert Jan de Borst, MD, PhD, Phone: +31 8875556965, Email: g.j.deborst-2@umcutrecht.nl
Additional Information

Related publications:

Nissen P, Brassard P, Jørgensen TB, Secher NH. Phenylephrine but not ephedrine reduces frontal lobe oxygenation following anesthesia-induced hypotension. Neurocrit Care. 2010 Feb;12(1):17-23. doi: 10.1007/s12028-009-9313-x.

Starting date: November 2011
Last updated: October 12, 2011

Page last updated: August 23, 2015

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