Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-25 @ 12:55 AM
Study NCT ID:
NCT06382467
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Remimazolam and Propofol Combination vs. Propofol in IOM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], '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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-21', 'studyFirstSubmitDate': '2024-04-17', 'studyFirstSubmitQcDate': '2024-04-21', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of intraoperative hypotension', 'timeFrame': 'operation day - postoperative 1 day', 'description': 'mean arterial pressure \\< 65mmHg'}], 'secondaryOutcomes': [{'measure': 'Amount and number of inotropic agents', 'timeFrame': 'operation day - postoperative 1 day', 'description': 'intraoperative inotropics amount (phenylephrine(mcg), ephedrine(mg), norepinephrine(mcg), dopamine(mg))'}, {'measure': "Incidence of participants' intraoperative involuntary movement", 'timeFrame': 'operation day - postoperative 1 day', 'description': 'number of patients involuntary movement during operation (ex. no movement:0 , 3 times of movement: 3)'}, {'measure': 'scores of neurophysiologic monitoring quality', 'timeFrame': 'operation day - postoperative 1 day', 'description': '0-5 scale of neurophysiologic monitoring quality, scored by neurophysiologic monitoring technologist (poor: 0, good: 5)'}, {'measure': 'onset time of study drugs', 'timeFrame': 'operation day - postoperative 1 day', 'description': 'time from administration of study drugs(remimazolam+propofol or propofol) to Bispectral index value \\< 60'}, {'measure': 'The administration number of rescue anti-emetic agents', 'timeFrame': 'operation day - postoperative 3 day', 'description': 'postoperative rescue anti-emetic agents (ramosetron, palonosetron, metoclopramide) requirements'}, {'measure': 'Time-weighted average of intraoperative hypotension', 'timeFrame': 'operation day - postoperative 1 day', 'description': '(depth of hypotension in millimeters of mercury below a MAP of 65mmHg × time in minutes spent below a MAP of 65mmHg)÷total duration of operation in minutes'}, {'measure': 'recovery time of study drugs (remimazolam+propofol or propofol)', 'timeFrame': 'operation day - postoperative 1 day', 'description': 'time from discontinuation of study drugs(remimazolam+propofol or propofol) to Bispectral index value \\> 60'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurologic Disorder']}, 'descriptionModule': {'briefSummary': "This study aims to compare total intravenous anesthetic agents: combined remimazolam and propofol vs. propofol monotherapy. The comparison parameters are intraoperative hypotension, patient's involuntary movement, neurophysiological monitoring quality, onset time, recovery time, and postoperative rescue anti-emetics requirements.", 'detailedDescription': 'This study hypothesizes that the combination regimen of remimazolam and propofol as total intravenous anesthesia in neurosurgical procedures requiring neurophysiological monitoring can reduce the incidence of hypotension compared to propofol monotherapy while providing comparable levels of neurophysiological monitoring and surgical conditions. With this hypothesis, the study aims to compare the frequency, severity, and duration of hypotension, frequency of patient movement, and appropriateness of neurophysiological monitoring between the combination therapy of remimazolam and propofol and propofol monotherapy in total intravenous anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 19 and above with planned neurosurgical procedures requiring neurophysiological monitoring, classified as American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3 in the United States.\n\nExclusion Criteria:\n\n1. Patients who refuse to participate in the study.\n2. Patients who are pregnant or lactating.\n3. Patients with hypersensitivity to the investigational drugs or to soy, peanuts, or Dextran 40.\n4. Patients with acute narrow-angle glaucoma.\n5. Patients with alcohol or drug dependence.\n6. Patients with hepatic impairment classified as Child-Pugh class C.\n7. Patients with lactose intolerance.\n8. Patients requiring emergency surgery.'}, 'identificationModule': {'nctId': 'NCT06382467', 'briefTitle': 'Comparison of Remimazolam and Propofol Combination vs. Propofol in IOM', 'organization': {'class': 'OTHER', 'fullName': 'Chung-Ang University Gwangmyeong Hospital'}, 'officialTitle': 'Comparison of Remimazolam and Propofol Combination vs. Propofol in Intraoperative Neurophysiologic Monitoring: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2401-136-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination group', 'description': 'Combination regimen (remimazolam plus propofol)', 'interventionNames': ['Drug: Remimazolam besylate + propofol MCT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol group', 'description': 'Propofol monotherapy', 'interventionNames': ['Drug: Propofol MCT']}], 'interventions': [{'name': 'Remimazolam besylate + propofol MCT', 'type': 'DRUG', 'description': 'remimazolam besylate 3mg/kg/hr for induction, and 0.5 mg/kg/hr for maintenance + propofol MCT 1-4 mcg/ml using target-controlled infusion', 'armGroupLabels': ['Combination group']}, {'name': 'Propofol MCT', 'type': 'DRUG', 'description': 'Propofol MCT 2-8 mcg/ml using target-controlled infusion', 'armGroupLabels': ['Propofol group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jiwon Han, Pf.', 'role': 'CONTACT', 'email': 'yesuroon@gmail.com', 'phone': '821034471988'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung-Ang University Gwangmyeong Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Jiwon Han', 'investigatorAffiliation': 'Chung-Ang University Gwangmyeong Hospital'}}}}