Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-02-20 @ 5:56 PM
Study NCT ID:
NCT03317535
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2017-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Choice of Anesthesia for Endovascular Treatment of Acute Ischemic Stroke in Posterior Circulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D000772', 'term': 'Anesthesia, Local'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-17', 'studyFirstSubmitDate': '2017-10-15', 'studyFirstSubmitQcDate': '2017-10-20', 'lastUpdatePostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified rankin score（mRS）', 'timeFrame': 'post-procedural 90 days', 'description': 'Modified rankin score（mRS）is used to evaluate the primary outcome. The scale of mRS is 0 to 6. The best neurological outcome is the mRS with 0, indicating no any symptom left, and a good neurological outcome is agreed with a mRS≤2. mRS of 6 is the worst, indicating death. mRS will be evaluated by outcomes assessor who is blinded to the grouping.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anesthesia Methods', 'Acute Ischemic Stroke', 'Endovascular Treatment'], 'conditions': ['Posterior Circulation Brain Infarction']}, 'referencesModule': {'references': [{'pmid': '36156704', 'type': 'DERIVED', 'citation': 'Liang F, Wu Y, Wang X, Yan L, Zhang S, Jian M, Liu H, Wang A, Wang F, Han R; CANVAS II Group. General Anesthesia vs Conscious Sedation for Endovascular Treatment in Patients With Posterior Circulation Acute Ischemic Stroke: An Exploratory Randomized Clinical Trial. JAMA Neurol. 2023 Jan 1;80(1):64-72. doi: 10.1001/jamaneurol.2022.3018.'}, {'pmid': '35857365', 'type': 'DERIVED', 'citation': 'Tosello R, Riera R, Tosello G, Clezar CN, Amorim JE, Vasconcelos V, Joao BB, Flumignan RL. Type of anaesthesia for acute ischaemic stroke endovascular treatment. Cochrane Database Syst Rev. 2022 Jul 20;7(7):CD013690. doi: 10.1002/14651858.CD013690.pub2.'}, {'pmid': '32737091', 'type': 'DERIVED', 'citation': 'Liang F, Zhao Y, Yan X, Wu Y, Li X, Zhou Y, Jian M, Li S, Miao Z, Han R, Peng Y. Choice of ANaesthesia for EndoVAScular treatment of acute ischaemic stroke at posterior circulation (CANVAS II): protocol for an exploratory randomised controlled study. BMJ Open. 2020 Jul 31;10(7):e036358. doi: 10.1136/bmjopen-2019-036358.'}]}, 'descriptionModule': {'briefSummary': 'There is few randomized controlled clinical to investigated the impact of anesthetic type on outcome in patients with acute ischemic stroke in posterior cerebral circulation. It is unknown whether the choice of anesthesia is impacted on the outcomes for these patients or not. The investigators will perform a randomized controlled pilot clinical trial of general anesthesia versus local anesthesia/conscious sedation to explore and find out a potential fact whether anesthetic type alters perioperative neurological function in patients with acute ischemic stroke in posterior cerebral circulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with acute ischemic stroke in posterior cerebral circulation scheduled to receive emergency endovascular treatment; Age \\> 18; The onset time is within 24 hours; Modified rankin score ≤2 before onset.\n\nExclusion Criteria:\n\n* Radiological ambiguity concerning infarction and vessel occlusion; Additional intracerebral hemorrhage; Anterior circulation infraction; Coma on admission (Glasgow coma score less than 8); NIHSS less than 6 or more than 30; Severe agitation or seizures on admission; Obvious loss of airway protective reflexes and/or vomiting on admission; Being intubated before treatment on admission; Known allergy to anesthetic or analgesic;'}, 'identificationModule': {'nctId': 'NCT03317535', 'acronym': 'CANVAS-II', 'briefTitle': 'Choice of Anesthesia for Endovascular Treatment of Acute Ischemic Stroke in Posterior Circulation', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Choice of Anesthesia for Endovascular Treatment of Acute Ischemic Stroke in Posterior Circulation: a Randomized Controlled Exploratory Study (CANVAS-Ⅱ)', 'orgStudyIdInfo': {'id': '2017-10-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Local anesthesia/conscious sedation', 'description': 'Patients will be injected by propofol (adjusted by bispectral index scale ≥70 ) and /or remifentanil（0.01-0.06μg/kg/min）. Patients will maintain spontaneous breathing.', 'interventionNames': ['Procedure: Local anesthesia/concious sedation', 'Procedure: Spontaneous breath']}, {'type': 'OTHER', 'label': 'General anesthesia', 'description': 'Patients will be induced with remifentanil (0.2-0.8 μg/kg), propofol (1-2mg/kg) and rocuronium (0.6 mg/kg). Anesthesia will then be maintained keep the BIS between 40 and 60 with propofol and remifentanil. After tracheal intubation, patients will be kept with controlled ventilation.', 'interventionNames': ['Procedure: General anesthesia', 'Procedure: Controlled ventilation']}], 'interventions': [{'name': 'General anesthesia', 'type': 'PROCEDURE', 'description': 'Patients will be injected with propofol, remifentanil and muscular relaxant with controlled ventilation.', 'armGroupLabels': ['General anesthesia']}, {'name': 'Local anesthesia/concious sedation', 'type': 'PROCEDURE', 'description': 'Patients will be injected with propofol and remifentanil.', 'armGroupLabels': ['Local anesthesia/conscious sedation']}, {'name': 'Spontaneous breath', 'type': 'PROCEDURE', 'description': 'Patients will be kept spontaneous breath.', 'armGroupLabels': ['Local anesthesia/conscious sedation']}, {'name': 'Controlled ventilation', 'type': 'PROCEDURE', 'description': 'Patient will be kept with controlled ventilation.', 'armGroupLabels': ['General anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Fengtai', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Ruquan Han', 'geoPoint': {'lat': 39.84757, 'lon': 116.27227}}, {'zip': '550014', 'city': 'Guiyang', 'state': 'Guizhou', 'country': 'China', 'facility': 'Fan Wang', 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}], 'overallOfficials': [{'name': 'Ruquan Han, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ruquan Han', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}