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

October 12, 2011 updated by: G.J. de Borst

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ephedrine
Drug: Administration of ephedrine
Ephedrine: 5- 10 mg
Active Comparator: Phenylephrine
Drug: Administration of phenylephrine
Phenylephrine: 50-100µg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

September 22, 2011

First Submitted That Met QC Criteria

October 12, 2011

First Posted (Estimate)

October 13, 2011

Study Record Updates

Last Update Posted (Estimate)

October 13, 2011

Last Update Submitted That Met QC Criteria

October 12, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-195

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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