Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-11 @ 3:19 PM
Study NCT ID:
NCT03910556
Status:
COMPLETED
Last Update Posted:
2019-04-12
First Post:
2019-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Re-craniotomy and Complications After Elective Neurosurgery
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': 'D015742', 'term': 'Propofol'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 439}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-11', 'studyFirstSubmitDate': '2019-04-06', 'studyFirstSubmitQcDate': '2019-04-08', 'lastUpdatePostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 're-craniotomy', 'timeFrame': 'the first 24 hours', 'description': 'number of participants who required re-craniotomy assessed by the neurosurgeon'}, {'measure': 'predictive factors of re-craniotomy', 'timeFrame': 'the first 24 hours', 'description': 'types of perioperative factors to predict the occurrence of re-craniotomy'}], 'secondaryOutcomes': [{'measure': 'incidence of major non-neurological complications', 'timeFrame': 'the first 24 hours', 'description': 'number of participants who develop any major systemic complications'}, {'measure': 'predictive factors of major non-neurological complications', 'timeFrame': 'the first 24 hours', 'description': 'types of predictive factors to predict the occurrence of major non-neurological complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['re-craniotomy', 'major non-neurological complications', 'neurosurgery', 'brain tumors'], 'conditions': ['Brain Tumor', 'Brain Metastases', 'Brain Cancer', 'Brain Neoplasms']}, 'descriptionModule': {'briefSummary': 'This study is a prospective cohort study to find the incidence of re-craniotomy and predictive factors. The secondary outcomes are to find the incidence of major non-neurological complications and predictive factors.', 'detailedDescription': 'Demographic data include age, gender, preoperative neurological assessment, diagnosis, operation, surgical position, ASA physical status, dexamethasone requirement, anticonvulsant therapy, airway assessment, and blood component reservation.\n\nIntraoperative information contain anesthetic technique, total dosage of propofol, fentanyl, and other anesthetic agents, total blood loss, types and amount of fluid replacement, volume of blood transfusion, latest body temperature, and the ability of safe extubation.\n\nPostoperative complications will be categorized in to general conditions, neurological complications, and systemic problems. General conditions such as on endotracheal tube overnight and postoperative blood transfusion. Neurological complications include worsen increased ICP, intracranial hematoma, seizures, newly-developed motor deficit, cranial nerve palsy, CSF rhinorrhea, and emergency re-craniotomy. Systemic problems are hypothermia, electrolyte imbalance, anemia, hypertension, and hyperglycemia. Postoperative nausea and vomiting and the rescued anti-emetic drugs will be recorded. Postoperative anti-epileptic drug (AED) and pain medication will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The adult patients who were scheduled for craniotomy to remove tumor', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are scheduled for elective craniotomy during 2017-2019\n* Patients who are planned for general anesthesia\n* Patients have read the study information and signed in the consent form\n\nExclusion Criteria:\n\n* Patients who are unable to understand and sign in the consent form\n* Patients who are scheduled for minor surgical procedures such as ventriculostomy and VP-shunt'}, 'identificationModule': {'nctId': 'NCT03910556', 'briefTitle': 'Re-craniotomy and Complications After Elective Neurosurgery', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'Predictive Factors of Re-craniotomy and Major Non-neurological Complications in Elective Neurosurgery: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'ANE-2561-05961'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'no complication', 'description': 'the patients who did not develop any kind of complication and no re-craniotomy', 'interventionNames': ['Drug: Propofol']}, {'label': 'with complication (s)', 'description': 'the patients who developed at least one of non-neurological complication or required re-craniotomy', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['surgical duration', 'operation', 'blood loss', 'blood used', 'fluid volume administration'], 'description': 'intraoperative factors', 'armGroupLabels': ['no complication', 'with complication (s)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pathomporn Pin-on, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chiang Mai University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yodying Punjasawadwong', 'class': 'UNKNOWN'}, {'name': 'Prangmalee Leucharussamee', 'class': 'UNKNOWN'}, {'name': 'Ananchanok Saringkarinkul', 'class': 'UNKNOWN'}, {'name': 'Patipan Krungsri', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Pathomporn Pin on, M.D.', 'investigatorAffiliation': 'Chiang Mai University'}}}}