Effect of Blood Pressure on rSO2 in Carotid Endarterectomy (CEA)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Intra-operative Hypotension Carotid Stenosis |
Drug: Administration of phenylephrine Drug: Administration of ephedrine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of Phenylephrine Versus Ephedrine on Cerebral Perfusion During Carotid Endarterectomy |
- 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. ] [ Designated as safety issue: No ]A continuous measurement during surgery will be performed. However for further analysis only a short time frame will be used.
- 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. ] [ Designated as safety issue: No ]A continuous measurement during surgery will be performed. However for further analysis only a short time frame will be used.
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Ephedrine |
Drug: Administration of ephedrine
Ephedrine: 5- 10 mg
|
| Active Comparator: Phenylephrine |
Drug: Administration of phenylephrine
Phenylephrine: 50-100µg
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations| Contact: Gert Jan de Borst, MD, PhD | +31 8875556965 | g.j.deborst-2@umcutrecht.nl |
| Contact: Claire Pennekamp, MD | +31 8875556965 | c.w.a.pennekamp-2@umcutrecht.nl |
| Netherlands | |
| University Medical Center Utrecht | Not yet recruiting |
| Utrecht, Netherlands, 3584 CX | |
| Contact: Gert Jan de Borst, MD, PhD +31 8875556965 g.j.deborst-2@umcutrecht.nl | |
| Study Director: | Gert Jan de Borst, MD, PhD | UMC Utrecht, The Netherlands |
| Principal Investigator: | Claire Pennekamp, MD | UMC Utrecht, The Netherlands |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | G.J. de Borst, Vascular surgeon; Head of cerebrovascular surgical programme., UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT01451294 History of Changes |
| Other Study ID Numbers: | 11-195 |
| Study First Received: | September 22, 2011 |
| Last Updated: | October 12, 2011 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by UMC Utrecht:
|
Cerebral autoregulation |
Additional relevant MeSH terms:
|
Carotid Stenosis Hypotension Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Ephedrine Phenylephrine Oxymetazoline Pseudoephedrine Central Nervous System Stimulants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Vasoconstrictor Agents Cardiovascular Agents Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nasal Decongestants Respiratory System Agents Bronchodilator Agents |
ClinicalTrials.gov processed this record on May 16, 2013