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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01451294
Other study ID # 11-195
Secondary ID
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


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
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