Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 6:13 AM
Study NCT ID:
NCT07377695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-30
First Post:
2026-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remimazolam Consumption: TCI vs. Manual Infusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009072', 'term': 'Moyamoya Disease'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002539', 'term': 'Cerebral Arterial Diseases'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014155', 'term': 'Transcobalamins'}, {'id': 'C522201', 'term': 'remimazolam'}], 'ancestors': [{'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-22', 'studyFirstSubmitDate': '2026-01-22', 'studyFirstSubmitQcDate': '2026-01-22', 'lastUpdatePostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Consumption of Remimazolam', 'timeFrame': 'From the start of anesthesia induction to the end of surgery (intraoperative period).', 'description': 'The total cumulative dose of remimazolam ($mg$) administered from the initiation of anesthesia induction until the completion of the surgical procedure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moyamoya Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective randomized controlled trial is to compare the total consumption of remimazolam between two different administration methods-Target-Controlled Infusion (TCI) and manual infusion-in patients undergoing cerebrovascular bypass surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled to undergo cerebrovascular bypass surgery under general anesthesia.\n* American Society of Anesthesiologists (ASA) Physical Status 1, 2, or 3\n* Adults aged 19 years or older\n* Patients who have provided prior written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Patients who do not consent to participate in the research\n* Patients classified as ASA Physical Status 4\n* Patients with a BMI ≤18.5 kg/m2 or 35.0 ≥ kg/m2\n* History of allergy to benzodiazepine-class medications\n* Patients with acute narrow-angle glaucoma\n* Patients in a state of shock or coma\n* Acute alcohol intoxication with suppressed vital signs , or patients with alcohol or drug dependency\n* Presence of Sleep Apnea Syndrome or severe/acute respiratory failure\n* Patients with lactose intolerance or hypersensitivity to Dextran 40'}, 'identificationModule': {'nctId': 'NCT07377695', 'briefTitle': 'Remimazolam Consumption: TCI vs. Manual Infusion', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparison of Remimazolam Consumption According to Administration Method in Patients Undergoing Cerebrovascular Bypass Surgery: A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'Bypass-TCI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TCI', 'description': 'Remimazolam administered via TCI (target Ce 0.7 μg/mL)', 'interventionNames': ['Other: Target-Controlled Infusion (TCI) of Remimazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Manual Infusion', 'description': 'Remimazolam administered via manual infusion (6 mg/kg/hr for induction, 1-2 mg/kg/hr for maintenance)', 'interventionNames': ['Other: Manual Infusion of Remimazolam']}], 'interventions': [{'name': 'Target-Controlled Infusion (TCI) of Remimazolam', 'type': 'OTHER', 'description': 'Remimazolam is administered using a target-controlled infusion (TCI) pump based on the Schuttler pharmacokinetic model. The initial target effect-site concentration (Ce) is set at 0.7 μg/mL and adjusted in 0.1 μg/mL increments to maintain a depth of anesthesia between Patient State Index (PSi) 25 and 50.', 'armGroupLabels': ['TCI']}, {'name': 'Manual Infusion of Remimazolam', 'type': 'OTHER', 'description': 'Remimazolam is administered via traditional manual weight-based infusion. For anesthesia induction, a rate of 6 mg/kg/hr is used. For maintenance, the infusion rate starts at 1 mg/kg/hr and is adjusted in 0.2 mg/kg/hr increments to maintain a PSi between 25 and 50.', 'armGroupLabels': ['Manual Infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Chang-Hoon Koo', 'role': 'CONTACT', 'email': 'vollock9@gmail.com', 'phone': '+82317877512'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Chang-Hoon Koo', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}