Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-15 @ 11:15 AM
Study NCT ID:
NCT02756312
Status:
UNKNOWN
Last Update Posted:
2020-09-09
First Post:
2016-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Anesthesia on High- Grade Glioma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000758', 'term': 'Anesthesia'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The anesthesiologist know the grouping .The subjects and the outcome assesor trained for telephone visit were blinded to the grouping'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a single centre, randomized, parallel group controlled clinical trial in patients with primary HGG. All eligible patients will be 1:1 randomized to the TIVA or INHA group. The object of the trail is to evaluate the effect of propofol or sevoflurane on the prognosis of supratentorial HGG patients after craniotomy.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 196}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-06', 'studyFirstSubmitDate': '2016-04-27', 'studyFirstSubmitQcDate': '2016-04-27', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival in18 months', 'timeFrame': 'Postoperative 18 months', 'description': 'overall survival in18 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia, Outcome, High-grade Glioma']}, 'referencesModule': {'references': [{'pmid': '36167574', 'type': 'DERIVED', 'citation': 'Dong J, Wang D, Sun H, Zeng M, Liu X, Yan X, Li R, Li S, Peng Y. Effect of anesthesia on the outcome of high-grade glioma patients undergoing supratentorial resection: study protocol for a pragmatic randomized controlled trial. Trials. 2022 Sep 27;23(1):816. doi: 10.1186/s13063-022-06716-9.'}]}, 'descriptionModule': {'briefSummary': 'Although bench data and retrospective studies have provided a promising picture of the possible influence of anesthetic technique on the risk of tumor progression and patients mortality, current evidence from RCTs is inadequate to show whether the type of anesthetics might influence tumor progression and patient survival.There are many thousands of patients with a cancer diagnosis undergoing surgery every year, and in the context of biological plausibility, it should lead to the urgent undertaking of RCTs to further evaluate the association between the anesthetic management and patient outcome.', 'detailedDescription': 'Although bench data and retrospective studies have provided a promising picture of the possible influence of anesthetic technique on the risk of tumor progression and patient mortality, current evidence from RCTs is inadequate to show whether the type of anesthetics might influence the outcome of the patients.There are many thousands of patients with a cancer diagnosis undergoing surgery every year, and in the context of biological plausibility, it should lead to the urgent undertaking of RCTs to further evaluate the association between the anesthetic management and patient outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1)Magnetic radiology imaging diagnosis of supratentorial high-grade glioma; 2) Patients undergoing tumor resection under selective general anesthesia; 3) Age 18-80 years old; 4) Preoperative KPS \\< 80; 5) With written informed consent by patients or their relatives.\n\nExclusion Criteria:\n\n1\\) History of other operations before; 2) Patients with recurrence and metastasis of gliomas or with malignant tumors of other organs; 3) Emergency operation; 4) Critical condition (ASA grade ≥ V before operation, Appendix 1, Severe liver and kidney dysfunction; 5) Patients with mental illness, severe dementia, language disorder, coma, and end-stage disease, etc.; 6) Pregnant or breastfeeding women; 7) Allergic to study drugs;8) Patients who need electrophysiological monitoring during operation. 9) Patients receiving reoperation with different anesthesia methods will be removed and the patients with the same anesthesia method will be continued to observe; 10) Postoperative pathological result is not high-grade glioma.'}, 'identificationModule': {'nctId': 'NCT02756312', 'briefTitle': 'The Impact of Anesthesia on High- Grade Glioma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'The Impact of Anesthesia on the Outcome of Supratentorial High- Grade Glioma Patients After Craniotomy', 'orgStudyIdInfo': {'id': 'ChiECRCT-20200049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intravenous anesthesia', 'description': 'Patients will receive total intravenous anesthesia undergoing brain tumor resection.', 'interventionNames': ['Other: IV Anesthesia']}, {'type': 'OTHER', 'label': 'Inhalation anesthesia', 'description': 'Patients will receive volatile inhalational anesthesia undergoing brain tumor resection.', 'interventionNames': ['Other: IH anesthesia']}], 'interventions': [{'name': 'IV Anesthesia', 'type': 'OTHER', 'description': 'The patients will receive intravenous anesthesia', 'armGroupLabels': ['Intravenous anesthesia']}, {'name': 'IH anesthesia', 'type': 'OTHER', 'description': 'The patients will receive inhalation anesthesia', 'armGroupLabels': ['Inhalation anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Yuming Peng', 'role': 'CONTACT'}, {'name': 'Jia Dong', 'role': 'CONTACT'}], 'facility': 'Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yuming Peng, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'florapym766@163.com', 'phone': '8610-59976656'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yuming Peng', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}