Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
Study NCT ID:
NCT06559566
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-19
First Post:
2024-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Postoperative Intracranial Pressure in Patients Undergoing Intracranial Tumor Surgery
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2024-07-31', 'studyFirstSubmitQcDate': '2024-08-15', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intracranial pressure', 'timeFrame': 'T0: Before anesthesia induction T1: peroperative5. minutes T2: At the end of the surgery 6.hours T3:after extubation 1 hours T4: postoperative 12.hours T5. postoperative 24.hours', 'description': 'To compare the optic nerve diameter measurement ,USG and BBT values used to measure intracranial pressure in patients with brain tumor surgery'}], 'secondaryOutcomes': [{'measure': 'Heart Rate', 'timeFrame': 'T0: Before anesthesia induction T1: preoperative 5.minutes T2: At the end of the surgery 6.hoursT3:after extubation 1 hours T4: postoperative 12.hours T5. postoperative 24.hours', 'description': 'To compare the heart rate measurement'}, {'measure': 'Blood pressure', 'timeFrame': 'T0: Before anesthesia induction T1: preoperative 5.minutes T2: At the end of the surgery 6.hours T3 extubation 1 hours T4: postoperative 12.hours T5. postoperative 24.hours', 'description': 'To compare the blood pressure measurement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OPTIC NERVE', 'INTRACRANIAL PRESSURE', 'INTRACRANIAL TUMOR', 'INTRACRANIAL TUMOR SURGERY', 'Intracranial Pressure Change'], 'conditions': ['INTRACRANIAL TUMOR', 'INTRACRANIAL PRESSURE', 'OPTIC NERVE']}, 'referencesModule': {'references': [{'pmid': '34270144', 'type': 'BACKGROUND', 'citation': 'Stevens RRF, Gommer ED, Aries MJH, Ertl M, Mess WH, Huberts W, Delhaas T. Optic nerve sheath diameter assessment by neurosonology: A review of methodologic discrepancies. J Neuroimaging. 2021 Sep;31(5):814-825. doi: 10.1111/jon.12906. Epub 2021 Jul 16.'}, {'pmid': '27852525', 'type': 'BACKGROUND', 'citation': 'Raffiz M, Abdullah JM. Optic nerve sheath diameter measurement: a means of detecting raised ICP in adult traumatic and non-traumatic neurosurgical patients. Am J Emerg Med. 2017 Jan;35(1):150-153. doi: 10.1016/j.ajem.2016.09.044. Epub 2016 Sep 23.'}, {'pmid': '37951461', 'type': 'BACKGROUND', 'citation': 'Xu J, Song Y, Shah Nayaz BM, Shi W, Zhao Y, Liu Y, Wu S, Li Z, Sun Y, Zhao Y, Yu W, Wang X. Optic Nerve Sheath Diameter Sonography for the Diagnosis of Intracranial Hypertension in Traumatic Brain Injury: A Systematic Review and Meta-Analysis. World Neurosurg. 2024 Feb;182:136-143. doi: 10.1016/j.wneu.2023.11.016. Epub 2023 Nov 10.'}]}, 'descriptionModule': {'briefSummary': 'Ultrasonography(USG)-guided optic nerve sheath diameter measurement and its correlation with brain computed tomography in the evaluation of intracranial pressure in patients who underwent intracranial brain tumor surgery.', 'detailedDescription': 'Optic Nerve Sheath Diameter (ONSD) Measurement is a non-invasive diagnostic method used to detect increased intracranial pressure, and in general, ONSD measurement over 5 mm has been found to be associated with increased intracranial pressure.ONSD will be measured using an USG device within the specified time periods.\n\nT0: Before anesthesia induction T1: First 5 minutes immediately after induction of anesthesia T2: At the end of the surgery before extubation /minute T3: Within the first hour/minute after extubation T4: 12 hours/minute after tumor resection T5. 24 hours/minute after tumor resection\n\nONSD measurement in brain computer tomography (BCT); Eyeball diameter and optic nerve diameter measurements will be made on BCT transverse images at the optic nerve level and recorded.In patients, USG and BCT correlation comparison is planned before the operation (T0), in the first hour after the end of post-operative surgery (T3) and at the 24th hour after post-operative surgery (T5).\n\nT0: ONSD measurement in pre-operative Brain CT T3: BCT ONSD measurement/minute within the first hour following the postoperative period T5: BCT ONSD measurement/minute 24 hours following the postoperative period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 -65 years\n* Brain malignant neoplasm tumor\n* Brain benign neoplasm supratentorial\n* Brain benign neoplasm infratentorial information\n\nExclusion Criteria:\n\n* Patients who cannot provide adequate image quality in ocular ultrasonography\n* Who are unconscious or have a Glasgow coma scale of less than 15\n* Pseudotumor cerebri\n* Optic nerve arachnoid cyst\n* Patients with open injuries involving the eyelid and surrounding area\n* Optic nerve malignant neoplasm\n* Injury of the optic nerve and its pathways\n* Systemic Lupus Erythematosis,\n* Scleroderma\n* Multiple Sclerosis, sarcoidosis\n* Thyrotoxicosis (hyperthyroidism)'}, 'identificationModule': {'nctId': 'NCT06559566', 'briefTitle': 'Evaluation of Postoperative Intracranial Pressure in Patients Undergoing Intracranial Tumor Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bagcilar Training and Research Hospital'}, 'officialTitle': 'Comparison of Two Methods Used to Asses Postoperative Intracranial Pressure in Patients Undergoing Intracranial Tumor Surgery', 'orgStudyIdInfo': {'id': 'BAGCILAR 3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ONSD measurement with USG', 'description': 'After the ONSD measurement is made before anesthesia induction, general anesthesia will be given to each patient according to the institutional protocol. The ONSD measurements of the patients will be measured according to the T0, T1, T2, T3, T4, T5 time period by a person who has experience in using USG T0: Before anesthesia induction T1: First 5 minutes immediately after induction of anesthesia T2: At the end of the surgery before extubation /minute T3: Within the first hour/minute after extubation T4: 12 hours/minute after tumor resection T5. 24 hours/minute after tumor resection', 'interventionNames': ['Procedure: USG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ONSD measurement with BCT', 'description': 'In patients, USG and BCT correlation comparison is planned before the operation (T0), in the first hour after the end of post-operative surgery (T3) and at the 24th hour after post-operative surgery (T5).\n\nT0: ONSD measurement in pre-operative BCT T3: BCT ONSD measurement/minute within the first hour following the postoperative period T5: BCT ONSD measurement/minute 24 hours following the postoperative period The measurement of ONSD in BCT is; Eyeball diameter and optic nerve diameter measurements will be made on BCT transverse images at the optic nerve level and recorded.', 'interventionNames': ['Procedure: BCT']}], 'interventions': [{'name': 'USG', 'type': 'PROCEDURE', 'otherNames': ['ONSD measurement with USG'], 'description': 'The aim of this study is to measure the intracranial pressure of patients planned for brain tumor surgery by measuring the optic nerve sheath diameter (ONSD) under USG guidance and compare its correlation with the computed brain tomography.', 'armGroupLabels': ['ONSD measurement with USG']}, {'name': 'BCT', 'type': 'PROCEDURE', 'otherNames': ['ONSD measurement with BCT'], 'description': 'The aim of this study is to measure the intracranial pressure of patients planned for brain tumor surgery by measuring the optic nerve sheath diameter (ONSD) under USG guidance and compare its correlation with the computed brain tomography.', 'armGroupLabels': ['ONSD measurement with BCT']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'SEZEN KUMAS SOLAK, MD', 'role': 'CONTACT', 'email': 'sezenkumassolak@gmail.com', 'phone': '+905055729494'}], 'overallOfficials': [{'name': 'SEZEN KUMAS SOLAK, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bagcılar Training Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The investigators will not share individual patient data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sezen Kumaş Solak', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Bagcilar Training and Research Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'SPONSOR INVESTIGATOR', 'investigatorFullName': 'Sezen Kumaş Solak', 'investigatorAffiliation': 'Bagcilar Training and Research Hospital'}}}}