Clinical trial NCT01451294: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Intra-operative Hypotension
Carotid Stenosis
Keywords: Cerebral autoregulation
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2011-10-13
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: cerebral perfusion (rSO2) measured using Near Infrared Spectroscopy
timeFrame: (day 1) Monitoring will take place only on the day of operation. No further follow-up. Timeframe is 1 day.
Secondary outcomes:
measure: Blood velocity (Vmca) measured using transcranial Doppler
timeFrame: 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.
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht, The Netherlands
name: Gert Jan de Borst, MD, PhD
role: STUDY_DIRECTOR
affiliation: UMC Utrecht, The Netherlands
name: Claire Pennekamp, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.