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

NCT01451294 | Unknown

• 1 other identifier: 11-195
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Intra-operative Hypotension; Carotid Stenosis

Keywords

Cerebral autoregulation

Outcome Measures

Primary Outcomes (1)

• cerebral perfusion (rSO2) measured using Near Infrared Spectroscopy

  A continuous measurement during surgery will be performed. However for further analysis only a short time frame will be used.

  (day 1) Monitoring will take place only on the day of operation. No further follow-up. Timeframe is 1 day.

Secondary Outcomes (1)

• Blood velocity (Vmca) measured using transcranial Doppler

  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.

Study Arms (2)

Ephedrine

ACTIVE COMPARATOR

Drug: Administration of ephedrine

Phenylephrine

ACTIVE COMPARATOR

Drug: Administration of phenylephrine

Interventions

Administration of phenylephrine DRUG

Phenylephrine: 50-100µg

Phenylephrine

Administration of ephedrine DRUG

Ephedrine: 5- 10 mg

Ephedrine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• All patients must have given written informed consent.

You may not qualify if:

• Not having a temporal bone window appropriate for TCD measurement
• Not willing to give informed consent.
• If the effect on BP of the given agents is insufficient (if relative hypotension persists five minutes after administration).

Sponsors & Collaborators

• G.J. de Borst: lead

Study Sites (1)

University Medical Center Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 19957053 BACKGROUND

• 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.

  PMID: 31190322 DERIVED

• 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.

  PMID: 27543526 DERIVED

• 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.

  PMID: 23410186 DERIVED

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gert Jan de Borst, MD, PhD

  UMC Utrecht, The Netherlands

  STUDY DIRECTOR

• Claire Pennekamp, MD

  UMC Utrecht, The Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gert Jan de Borst, MD, PhD

CONTACT

+31 8875556965; g.j.deborst-2@umcutrecht.nl

Claire Pennekamp, MD

CONTACT

+31 8875556965; c.w.a.pennekamp-2@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vascular surgeon; Head of cerebrovascular surgical programme.

Study Record Dates

• First Submitted: September 22, 2011
• First Posted: October 13, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: October 13, 2011

Record last verified: 2011-10

Locations

NL (1)