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

Carotid Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01451294
• Other study ID #: 11-195
• Status: Not yet recruiting
• Phase: N/A
• First received: September 22, 2011
• Last updated: October 12, 2011
• Start date: November 2011
• Est. completion date: March 2012

Study information

• Verified date: October 2011
• Source: UMC Utrecht
• Contact: Gert Jan de Borst, MD, PhD
• Phone: +31 8875556965
• Email: g.j.deborst-2[@]umcutrecht.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Stenosis
• Hypotension
• Intra-operative Hypotension

Intervention

Drug:
• Administration of phenylephrine
Phenylephrine: 50-100µg
• Administration of ephedrine
Ephedrine: 5- 10 mg

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
G.J. de Borst

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Nissen P, Brassard P, Jørgensen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	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.	No