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

NCT ID: NCT01451294

Last Updated: 2011-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intra-operative Hypotension Carotid Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ephedrine

Group Type ACTIVE_COMPARATOR

Administration of ephedrine

Intervention Type DRUG

Ephedrine: 5- 10 mg

Phenylephrine

Group Type ACTIVE_COMPARATOR

Administration of phenylephrine

Intervention Type DRUG

Phenylephrine: 50-100µg

Interventions

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Administration of phenylephrine

Phenylephrine: 50-100µg

Intervention Type DRUG

Administration of ephedrine

Ephedrine: 5- 10 mg

Intervention Type DRUG

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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G.J. de Borst

OTHER

Sponsor Role lead

Responsible Party

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G.J. de Borst

Vascular surgeon; Head of cerebrovascular surgical programme.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gert Jan de Borst, MD, PhD

Role: STUDY_DIRECTOR

UMC Utrecht, The Netherlands

Claire Pennekamp, MD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht, The Netherlands

Locations

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University Medical Center Utrecht

Utrecht, Utrecht, Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Gert Jan de Borst, MD, PhD

Role: CONTACT

[email protected]
+31 8875556965

Claire Pennekamp, MD

Role: CONTACT

[email protected]
+31 8875556965

Facility Contacts

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Gert Jan de Borst, MD, PhD

Role: primary

[email protected]
+31 8875556965

References

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Nissen P, Brassard P, Jorgensen 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.

Reference Type BACKGROUND
PMID: 19957053 (View on PubMed)

Fassaert LMM, de Borst GJ, Pennekamp CWA, Specken-Welleweerd JC, Moll FL, van Klei WA, Immink RV. Effect of Phenylephrine and Ephedrine on Cerebral (Tissue) Oxygen Saturation During Carotid Endarterectomy (PEPPER): A Randomized Controlled Trial. Neurocrit Care. 2019 Dec;31(3):514-525. doi: 10.1007/s12028-019-00749-w.

Reference Type DERIVED
PMID: 31190322 (View on PubMed)

Heusdens JF, Lof S, Pennekamp CW, Specken-Welleweerd JC, de Borst GJ, van Klei WA, van Wolfswinkel L, Immink RV. Validation of non-invasive arterial pressure monitoring during carotid endarterectomy. Br J Anaesth. 2016 Sep;117(3):316-23. doi: 10.1093/bja/aew268.

Reference Type DERIVED
PMID: 27543526 (View on PubMed)

Pennekamp CW, Immink RV, Buhre WF, Moll FL, de Borst GJ. Phenylephrine versus ephedrine on cerebral perfusion during carotid endarterectomy (PEPPER): study protocol for a randomized controlled trial. Trials. 2013 Feb 14;14:43. doi: 10.1186/1745-6215-14-43.

Reference Type DERIVED
PMID: 23410186 (View on PubMed)

Other Identifiers

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11-195

Identifier Type: -

Identifier Source: org_study_id