Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT03498235
Status:
UNKNOWN
Last Update Posted:
2020-06-23
First Post:
2018-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Sevoflurane and Propofol on Optic Nerve Sheath Diameter During Laparoscopic Gynecologic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-19', 'studyFirstSubmitDate': '2018-03-08', 'studyFirstSubmitQcDate': '2018-04-06', 'lastUpdatePostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of ultrasonographic optic nerve sheath diameter', 'timeFrame': 'from the time when patients enter into operation room to the time when the surgery ending', 'description': 'different time including pre-anesthesia, after intubation,every 15 minutes in the first hour after beginning of surgery, every hour when one hour after surgery beginning,surgery ending.'}], 'secondaryOutcomes': [{'measure': 'Analyzed whether mean arterial pressure influence the change of ONSD based on 110 patients in two groups.', 'timeFrame': 'from the time when patients enter into operation room to the time when the surgery ending', 'description': 'Mean arterial pressure was collected when measures ONSD by ultrasound.'}, {'measure': 'Analyzed whether airway pressure influence the change of ONSD based on 110 patients in two groups.', 'timeFrame': 'from the time when patients enter into operation room to the time when the surgery ending', 'description': 'airway pressure was collected when measures ONSD by ultrasound.'}, {'measure': 'Analyzed whether urine volume influence the change of ONSD based on 110 patients in two groups.', 'timeFrame': 'from the time when patients enter into operation room to the time when the surgery ending', 'description': 'Recording urine volume when the surgery finished.'}, {'measure': 'Analyzed whether blood loss influence the change of ONSD based on 110 patients in two groups.', 'timeFrame': 'from the time when patients enter into operation room to the time when the surgery ending', 'description': 'Recording blood loss when the surgery finished.'}, {'measure': 'Analyzed whether fluid volume influence the change of ONSD based on 110 patients in two groups.', 'timeFrame': 'from the time when patients enter into operation room to the time when the surgery ending', 'description': 'Recording fluid volume when the surgery finished.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sevoflurane', 'propofol', 'intracranial pressure', 'optic nerve sheath diameter'], 'conditions': ['Laparoscopic Gynecologic Surgery']}, 'referencesModule': {'references': [{'pmid': '33504329', 'type': 'DERIVED', 'citation': 'Geng W, Chen C, Sun X, Huang S. Effects of sevoflurane and propofol on the optic nerve sheath diameter in patients undergoing laparoscopic gynecological surgery: a randomized controlled clinical studies. BMC Anesthesiol. 2021 Jan 27;21(1):30. doi: 10.1186/s12871-021-01243-7.'}]}, 'descriptionModule': {'briefSummary': 'Intracranial pressure（ICP) increases during laparoscopic gynecologic surgery increase (ICP) and may alter optic nerve sheath diameter(ONSD).This study measures ONSD in different team because sevoflurane and propofol have different effects on ICP.Half of participants will receive sevoflurane anesthesia,while the other half undergo propofol anesthesia.', 'detailedDescription': 'Due to the anatomical and physiological characteristics of optic nerve sheath ,ONSD increases when ICP rises.\n\nSevoflurane and propofol have different effects on ICP.When sevoflurane concentration \\>1.1 minimum alveolar concentration（MAC),ICP increases because of cerebral vasodilatation；on the other hand ,propofol constricts the blood vessels and ICP decreases.\n\nICP increases during laparoscopic gynecologic surgery because of steep Trendelenburg position and pneumoperitoneum .\n\nMeanwhile,sevoflurane affects self regulation of cerebral blood flow on the way of dose dependent,but propofol has no effects on self regulation of cerebral blood flow.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists physical status diagnosed as I or II\n\nExclusion Criteria:\n\n* neuromuscular diseases;laboratory abnormalities in electrolytes; liver and kidney dysfunction;allergy to general anesthetics;pregnancy;ocular lesions including ocular trauma, optic neuritis, optic nerve tumor.'}, 'identificationModule': {'nctId': 'NCT03498235', 'briefTitle': 'Effects of Sevoflurane and Propofol on Optic Nerve Sheath Diameter During Laparoscopic Gynecologic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Obstetrics & Gynecology Hospital of Fudan University'}, 'officialTitle': 'Randomized,Double-Blind Trial A Comparative Analysis of the Effects of Sevoflurane and Propofol on Optic Nerve Sheath Diameter During Steep Trendelenburg Position and Pneumoperitoneum for Laparoscopic Gynecologic Surgery', 'orgStudyIdInfo': {'id': 'V2018-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Team Sevoflurane', 'interventionNames': ['Drug: Sevoflurane']}, {'type': 'EXPERIMENTAL', 'label': 'Team Propofol', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Sevoflurane', 'type': 'DRUG', 'description': 'In Team Sevoflurane,patients undergo sevoflurane.', 'armGroupLabels': ['Team Sevoflurane']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'In Team Propofol ,anesthesia is maintained with propofol', 'armGroupLabels': ['Team Propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200090', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Obstetrics & Gynecology Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Obstetrics & Gynecology Hospital of Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director,Clinical Research', 'investigatorFullName': 'Weilian Geng', 'investigatorAffiliation': 'Obstetrics & Gynecology Hospital of Fudan University'}}}}