Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-03-16 @ 9:36 AM
Study NCT ID:
NCT01451294
Status:
UNKNOWN
Last Update Posted:
2011-10-13
First Post:
2011-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Blood Pressure on rSO2 in Carotid Endarterectomy (CEA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-10-12', 'studyFirstSubmitDate': '2011-09-22', 'studyFirstSubmitQcDate': '2011-10-12', 'lastUpdatePostDateStruct': {'date': '2011-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'description': 'A continuous measurement during surgery will be performed. However for further analysis only a short time frame will be used.'}], 'secondaryOutcomes': [{'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.', 'description': 'A continuous measurement during surgery will be performed. However for further analysis only a short time frame will be used.'}]}, 'conditionsModule': {'keywords': ['Cerebral autoregulation'], 'conditions': ['Intra-operative Hypotension', 'Carotid Stenosis']}, 'referencesModule': {'references': [{'pmid': '19957053', 'type': 'BACKGROUND', '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.'}, {'pmid': '31190322', 'type': 'DERIVED', '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.'}, {'pmid': '27543526', 'type': 'DERIVED', '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.'}, {'pmid': '23410186', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nTherefore, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. 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.\n2. All patients must have given written informed consent.\n\nExclusion criteria:\n\n1. Not having a temporal bone window appropriate for TCD measurement\n2. Not willing to give informed consent.\n3. If the effect on BP of the given agents is insufficient (if relative hypotension persists five minutes after administration).'}, 'identificationModule': {'nctId': 'NCT01451294', 'briefTitle': 'Effect of Blood Pressure on rSO2 in Carotid Endarterectomy (CEA)', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'The Effect of Phenylephrine Versus Ephedrine on Cerebral Perfusion During Carotid Endarterectomy', 'orgStudyIdInfo': {'id': '11-195'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ephedrine', 'interventionNames': ['Drug: Administration of ephedrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phenylephrine', 'interventionNames': ['Drug: Administration of phenylephrine']}], 'interventions': [{'name': 'Administration of phenylephrine', 'type': 'DRUG', 'description': 'Phenylephrine: 50-100µg', 'armGroupLabels': ['Phenylephrine']}, {'name': 'Administration of ephedrine', 'type': 'DRUG', 'description': 'Ephedrine: 5- 10 mg', 'armGroupLabels': ['Ephedrine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3584 CX', 'city': 'Utrecht', 'state': 'Utrecht', 'country': 'Netherlands', 'contacts': [{'name': 'Gert Jan de Borst, MD, PhD', 'role': 'CONTACT', 'email': 'g.j.deborst-2@umcutrecht.nl', 'phone': '+31 8875556965'}], 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'centralContacts': [{'name': 'Gert Jan de Borst, MD, PhD', 'role': 'CONTACT', 'email': 'g.j.deborst-2@umcutrecht.nl', 'phone': '+31 8875556965'}, {'name': 'Claire Pennekamp, MD', 'role': 'CONTACT', 'email': 'c.w.a.pennekamp-2@umcutrecht.nl', 'phone': '+31 8875556965'}], 'overallOfficials': [{'name': 'Gert Jan de Borst, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UMC Utrecht, The Netherlands'}, {'name': 'Claire Pennekamp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht, The Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'G.J. de Borst', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Vascular surgeon; Head of cerebrovascular surgical programme.', 'investigatorFullName': 'G.J. de Borst', 'investigatorAffiliation': 'UMC Utrecht'}}}}