Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-04 @ 4:47 PM
Study NCT ID:
NCT02193568
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2014-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Light Sedation or Intubated General Anesthesia in Patients With Brain Cancer Undergoing Craniotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-30'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-11', 'studyFirstSubmitDate': '2014-06-19', 'studyFirstSubmitQcDate': '2014-07-15', 'lastUpdatePostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare overall hospital length of stay for patients in each of 2 arms', 'timeFrame': 'Up to 1 year', 'description': 'Will be summarized for each arm and compared between light sedation and general anesthesia arm using two-sample test. Regression model will also be used to study the association between the length of stay and the type of anesthesia with potential confounder variables.'}], 'secondaryOutcomes': [{'measure': 'Compare resource utilization between two groups', 'timeFrame': 'Up to 1 year', 'description': 'Compare costs of hospital stay, anesthesia, and surgery'}, {'measure': 'Assess the frequency of post-operative delirium', 'timeFrame': 'Up to 1 year', 'description': 'Post-operative delirium will be assessed using the Memorial Delirium Assessment Scale (MDAS); a tool developed to measure the severity of delirium and reflects the main diagnostic criteria and symptoms of delirium. The MDAS is structured as a ten-item, four-point clinician-rated scale (possible range, 0-30) designed to quantify the severity of delirium in medically ill patients. A score of 13 has been recommended by the original authors as a cutoff for establishing the diagnosis of delirium.'}, {'measure': 'Measure patient perceptions', 'timeFrame': 'Up to 1 year', 'description': 'Will be measured by asking patients about their overall positive experiences, if they understood rationale behind non-intubated craniotomy; necessary to improve outcomes and minimize complications; self-protection/preservation, if they appreciated receiving information before surgery to help them make informed decisions, and their trust in the surgeon via survey to be conducted at the conclusion of the inpatient stay, before hospital discharge'}, {'measure': 'Track patient complications during hospital stay', 'timeFrame': 'Up to 1 year', 'description': 'Track patient nausea/vomiting, pain, hematology/lab stability, hemodynamic stability'}, {'measure': 'Track re-admission and extended hospital stay rates', 'timeFrame': 'Up to 1 year from the date of surgery', 'description': 'Tracking will be done using the EMR and follow-up calls'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Supratentorial Glioma', 'Craniotomy'], 'conditions': ['Adult Brain Tumor']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'The Jamesline'}]}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial studies light sedation compared with intubated general anesthesia (a loss of feeling and a complete loss of awareness that feels like a very deep sleep) in reducing complications and length of hospital stay in patients with brain cancer undergoing craniotomy. Craniotomy is an operation in which a piece of the skull is removed so doctors can remove a brain tumor or abnormal brain tissue. Light sedation allows patients to remain awake during their surgery, while intubated general anesthesia puts patients to sleep. Surgery complication rates may be reduced if intubated general anesthesia is avoided. Additionally, patients not receiving intubated general anesthesia tend to recover more quickly after surgery. It is not yet known whether light sedation is better at reducing complications and length of hospital stay compared to intubated general anesthesia.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To compare the overall hospital length of stay (LOS) in patients undergoing craniotomy with light sedation vs. general anesthesia.\n\nSECONDARY OBJECTIVES:\n\nI. To compare resource utilization between the two groups. II. To assess the frequency of post-operative delirium. III. To measure patient perceptions. IV. To track patient complications during hospital stay - nausea/vomiting, pain, hematology/lab stability, hemodynamic stability.\n\nV. To track re-admission and extended hospital stay rates. VI. To compare cost of both approaches.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients receive light sedation (awake) and undergo craniotomy.\n\nARM II: Patients receive intubated general anesthesia and undergo craniotomy.\n\nAfter completion of study, patients are followed up at 1month and 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-pregnant females\n* Elective craniotomy for supratentorial brain tumors\n* Primary brain cancer (presumed gliomas with no radiographic or clinical evidence of metastatic disease to the brain)\n* First craniotomy\n* American Society of Anesthesiologists (ASA) I-III\n* Body mass index (BMI) \\< 35\n\nExclusion Criteria:\n\n* Posterior fossa tumor/approach for tumor resection requiring the prone position\n* Traumatic lesions/hematomas\n* Emergency case\n* Systemic disease burden with metastatic tumor to the brain\n* Presence of medical co-morbidities, which, in the opinion of the investigator complicates the surgical procedure or would require additional hospital stay\n* Necessity of awake procedure requiring intraoperative participation of patient due to the presence of the lesion in eloquent brain areas\n* Prisoners\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT02193568', 'briefTitle': 'Light Sedation or Intubated General Anesthesia in Patients With Brain Cancer Undergoing Craniotomy', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'A Prospective, Single-Blinded, Randomized Study of Awake vs Intubated General Anesthesia in Patients Undergoing Elective Craniotomy for Supratentorial Glioma Resection', 'orgStudyIdInfo': {'id': 'OSU-12161'}, 'secondaryIdInfos': [{'id': 'NCI-2014-01110', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (light sedation)', 'description': 'Patients receive light sedation (awake) and undergo craniotomy.', 'interventionNames': ['Procedure: Arm I (light sedation)', 'Procedure: Arm II (intubated general anesthesia)', 'Other: Arm II (intubated general anesthesia)', 'Other: Arm I (light sedation)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (intubated general anesthesia)', 'description': 'Patients receive intubated general anesthesia and undergo craniotomy.', 'interventionNames': ['Procedure: Arm II (intubated general anesthesia)', 'Other: Arm II (intubated general anesthesia)', 'Procedure: Arm I (light sedation)', 'Other: Arm I (light sedation)']}], 'interventions': [{'name': 'Arm I (light sedation)', 'type': 'PROCEDURE', 'otherNames': ['anesthesia'], 'description': 'If patients experience excessive preoperative anxiety they will receive light sedation of midazolam 1 mg IV.In our standard practice, it is very rare that patients receive anxiolytic premedication for craniotomies, so it is unlikely that many will require midazolam. Two IVs will be placed, one for infusion of meds and one for possible resuscitation.', 'armGroupLabels': ['Arm I (light sedation)']}, {'name': 'Arm II (intubated general anesthesia)', 'type': 'PROCEDURE', 'otherNames': ['general anesthesia'], 'description': 'Receive intubated general anesthesia', 'armGroupLabels': ['Arm II (intubated general anesthesia)']}, {'name': 'Arm II (intubated general anesthesia)', 'type': 'PROCEDURE', 'otherNames': ['therapeutic conventional surgery'], 'description': 'Undergo craniotomy', 'armGroupLabels': ['Arm I (light sedation)', 'Arm II (intubated general anesthesia)']}, {'name': 'Arm II (intubated general anesthesia)', 'type': 'OTHER', 'otherNames': ['questionnaire administration'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (light sedation)', 'Arm II (intubated general anesthesia)']}, {'name': 'Arm I (light sedation)', 'type': 'PROCEDURE', 'otherNames': ['therapeutic conventional surgery'], 'description': 'Undergo craniotomy', 'armGroupLabels': ['Arm I (light sedation)', 'Arm II (intubated general anesthesia)']}, {'name': 'Arm I (light sedation)', 'type': 'OTHER', 'otherNames': ['questionnaire administration'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (light sedation)', 'Arm II (intubated general anesthesia)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'James Elder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'James Elder', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}