Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-24 @ 4:03 PM
Study NCT ID:
NCT05774366
Status:
UNKNOWN
Last Update Posted:
2023-09-07
First Post:
2023-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Study of Recovery Characteristics Between Remimazolam Anesthesia With Flumazenil and Desflurane Anesthesia for Closed Reduction of Nasal Bone Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C522201', 'term': 'remimazolam'}, {'id': 'D000077335', 'term': 'Desflurane'}], 'ancestors': [{'id': 'D005019', 'term': 'Ethyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2023-03-07', 'studyFirstSubmitQcDate': '2023-03-07', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to follow verbal command', 'timeFrame': "from discontinuation of anesthetic agent to response to a verbal command of moving participant's foot, up to 30 minutes", 'description': "Time between discontinuation of anesthetic agent and response to a verbal command of moving participant's foot"}], 'secondaryOutcomes': [{'measure': 'time to eye opening', 'timeFrame': 'from discontinuation of anesthetic agent to eye opening, up to 30 minutes', 'description': 'Time between discontinuation of anesthetic agent and eye opening'}, {'measure': 'time to extubation', 'timeFrame': 'form discontinuation of anesthetic agent to extubation, up to 30 minutes', 'description': 'Time between discontinuation of anesthetic agent and extubation'}, {'measure': 'Incidence of agitation during emergence period', 'timeFrame': 'from discontinuation of anesthetic agent to 2 minutes after extubation', 'description': 'Ricker Sedation-Agitation Scale (RSAS) \\>4'}, {'measure': 'Mean arterial blood pressure', 'timeFrame': 'from 5 minutes before anesthesia induction to end of anesthesia', 'description': 'Mean arterial blood pressure measured in the operating room'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': "The goal of this prospective, randomized study is to compare recovery characteristics between remimazolam anesthesia with flumazenil and desflurane anesthesia in patients undergoing closed reduction of nasal bone fracture. The main question this study aims to answer is:\n\n* Is there statistically significant difference in time from discontinuation of the anesthetic agent up to patient's response to verbal command between these two groups?\n\nParticipants will receive either remimazolam or desflurane for the maintenance of general anesthesia. When the surgery ends, the anesthetic agent will be stopped. For Remimazolam group, flumazenil will be administered as an antagonist of remimazolam."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 19 and 75 years\n* American Society of Anesthesiologists physical status (ASA PS) of I-II\n* Patients undergoing elective closed reduction of nasal bone fracture\n\nExclusion Criteria:\n\n* Patient who cannot understand the process of this study\n* Cognitive, visual or hearing impairment\n* Chronic use of antipsychotic medications or medications for sleeping problem\n* Use of benzodiazepine\n* Patient with kidney or liver disease\n* Body mass index (BMI) \\>30 kg/m\\^2'}, 'identificationModule': {'nctId': 'NCT05774366', 'briefTitle': 'Comparative Study of Recovery Characteristics Between Remimazolam Anesthesia With Flumazenil and Desflurane Anesthesia for Closed Reduction of Nasal Bone Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Daegu Catholic University Medical Center'}, 'officialTitle': 'Comparative Study of Recovery Characteristics Between Remimazolam Anesthesia With Flumazenil and Desflurane Anesthesia for Closed Reduction of Nasal Bone Fracture', 'orgStudyIdInfo': {'id': 'CR-23-007-L'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remimazolam group', 'description': 'receives remimazolam for the maintenance of general anesthesia. At the end of surgery, flumazenil is administered as an antagonist of remimazolam.', 'interventionNames': ['Drug: Remimazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Desflurane group', 'description': 'receives desflurane for the maintenance of general anesthesia.', 'interventionNames': ['Drug: Desflurane']}], 'interventions': [{'name': 'Remimazolam', 'type': 'DRUG', 'description': 'General anesthesia was induced with 12 mg/kg/hr of intravenous remimazolam. When loss of consciousness was achieved, the infusion rate of remimazolam was reduced to 1mg/kg/hr for maintenance. At the end of surgery, 0.2 mg of flumazenil is administered.', 'armGroupLabels': ['Remimazolam group']}, {'name': 'Desflurane', 'type': 'DRUG', 'description': 'Desflurane (1 minimum alveolar concentration (MAC) of end-tidal desflurane concentration) is used for the maintenance of general anesthesia. Induction of general anesthesia is achieved with 1-2 mg/kg of intravenous propofol bolus.', 'armGroupLabels': ['Desflurane group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42472', 'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'So Young Lee, M.D.', 'role': 'CONTACT', 'email': 'slamfor01@gmail.com', 'phone': '+82-53-650-4885'}, {'name': 'Jong Hae Kim, M.D.', 'role': 'CONTACT', 'email': 'usmed12@gmail.com', 'phone': '+82-53-650-4979'}, {'name': 'So Young Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jong Hae Kim, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Daegu Catholic University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'centralContacts': [{'name': 'So Young Lee, M.D.', 'role': 'CONTACT', 'email': 'slamfor01@gmail.com', 'phone': '+82-53-650-4885'}, {'name': 'Jonghae Kim, M.D.', 'role': 'CONTACT', 'email': 'usmed12@gmail.com', 'phone': '+82-53-650-4979'}], 'overallOfficials': [{'name': 'So Young Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Daegu Catholic University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daegu Catholic University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'SO YOUNG LEE', 'investigatorAffiliation': 'Daegu Catholic University Medical Center'}}}}