Effect of Blood Pressure on rSO2 in Carotid Endarterectomy (CEA)
Primary Purpose
Intra-operative Hypotension, Carotid Stenosis
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Administration of phenylephrine
Administration of ephedrine
Sponsored by
About this trial
This is an interventional treatment trial for Intra-operative Hypotension focused on measuring Cerebral autoregulation
Eligibility Criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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).
Sites / Locations
- University Medical Center Utrecht
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ephedrine
Phenylephrine
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Blood velocity (Vmca) measured using transcranial Doppler
A continuous measurement during surgery will be performed. However for further analysis only a short time frame will be used.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01451294
Brief Title
Effect of Blood Pressure on rSO2 in Carotid Endarterectomy (CEA)
Official Title
The Effect of Phenylephrine Versus Ephedrine on Cerebral Perfusion During Carotid Endarterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
G.J. de Borst
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intra-operative Hypotension, Carotid Stenosis
Keywords
Cerebral autoregulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ephedrine
Arm Type
Active Comparator
Arm Title
Phenylephrine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Administration of phenylephrine
Intervention Description
Phenylephrine: 50-100µg
Intervention Type
Drug
Intervention Name(s)
Administration of ephedrine
Intervention Description
Ephedrine: 5- 10 mg
Primary Outcome Measure Information:
Title
cerebral perfusion (rSO2) measured using Near Infrared Spectroscopy
Description
A continuous measurement during surgery will be performed. However for further analysis only a short time frame will be used.
Time Frame
(day 1) Monitoring will take place only on the day of operation. No further follow-up. Timeframe is 1 day.
Secondary Outcome Measure Information:
Title
Blood velocity (Vmca) measured using transcranial Doppler
Description
A continuous measurement during surgery will be performed. However for further analysis only a short time frame will be used.
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.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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.
Exclusion criteria:
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gert Jan de Borst, MD, PhD
Phone
+31 8875556965
Email
g.j.deborst-2@umcutrecht.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Pennekamp, MD
Phone
+31 8875556965
Email
c.w.a.pennekamp-2@umcutrecht.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gert Jan de Borst, MD, PhD
Organizational Affiliation
UMC Utrecht, The Netherlands
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Claire Pennekamp, MD
Organizational Affiliation
UMC Utrecht, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gert Jan de Borst, MD, PhD
Phone
+31 8875556965
Email
g.j.deborst-2@umcutrecht.nl
12. IPD Sharing Statement
Citations:
PubMed Identifier
19957053
Citation
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.
Results Reference
background
PubMed Identifier
31190322
Citation
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.
Results Reference
derived
PubMed Identifier
27543526
Citation
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.
Results Reference
derived
PubMed Identifier
23410186
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Blood Pressure on rSO2 in Carotid Endarterectomy (CEA)
We'll reach out to this number within 24 hrs