Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT05382806
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2022-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reversal of Remimazolam by a Single Dose of Flumazenil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005442', 'term': 'Flumazenil'}], 'ancestors': [{'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'participants and outcome assessors are blinded to which group participants are allocated.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are administered either flumazenil (group flumazenil) or 0.9% normal saline (group control).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-18', 'studyFirstSubmitDate': '2022-05-11', 'studyFirstSubmitQcDate': '2022-05-17', 'lastUpdatePostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of postoperative nausea and vomiting (PONV)', 'timeFrame': 'up to 24 hours after participants discharge from day surgery center.', 'description': 'assess PONV with ordinal scale; 0=none, 1= nausea, 2= retching, 3=vomiting'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Flumazenil Adverse Reaction', 'Ambulatory Surgery', 'Postoperative Nausea', 'Remimazolam']}, 'descriptionModule': {'briefSummary': 'Remimazolam, a brand-new sedative which has benzodiazepine property. It is an ultra-short acting sedative and regarded as a proper drug for procedural sedation.', 'detailedDescription': "As ambulatory surgery has been increased last two decades, 'Enhanced Recovery After Surgery (ERAS)' also has become an important issue in clinical fields.\n\nIt is very critical that managing postoperative pain, postoperative nausea and vomiting (PONV) and rapid recovery with less complication or side effect to anesthesiologists.\n\nEven though remimazolam considered as an ultra-short acting sedative, it shows a relatively longer recovery time than propofol. Fortunately, remimazolam has its own antidote, called 'flimazenil'. With flumazenil, the time to recovery of consciousness dramatically reduces.\n\nCommon side effects of flumazenil include headache, dizziness, nausea, vomiting, flushing, sweating and injection pain.\n\nIn this trial we would like to demonstrate that routine single dose of flumazenil could be administered as an antidote of remimazolam without complications or side effects in gynecologic ambulatory surgery."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participants aged over 20 years scheduled for ambulatory gynecologic surgery.\n\nExclusion Criteria:\n\n* allergy or hypersensitivity to flumazenil, benzodiazepines, NSAIDs, 5-HT3\n* arrhythmia, myocardial infarction, coronary artery disease\n* obstructive sleep apnea\n* severe or acute respiratory distress\n* tricyclic anti-depressant\n* lactose intolerance\n* BMI over 30kg/m2\n* ASA classification 4 or 5'}, 'identificationModule': {'nctId': 'NCT05382806', 'briefTitle': 'Reversal of Remimazolam by a Single Dose of Flumazenil', 'organization': {'class': 'OTHER', 'fullName': 'Konkuk University Medical Center'}, 'officialTitle': 'Reversal of Remimazolam by a Single Dose of Flumazenil After Monitored Anesthesia Care in Gynecological Ambulatory Surgery: a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KUMC2021-11-058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'group Control', 'description': 'participants are administered 2mL of 0.9% placebo at the end of procedure.', 'interventionNames': ['Drug: Flumazenil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group Flumazenil', 'description': 'participants are administered 0.2mg (2mL) of flumazenil at the end of procedure.', 'interventionNames': ['Drug: Flumazenil']}], 'interventions': [{'name': 'Flumazenil', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'During the procedure, continuous infusion of remimazolam dose of 2mg/kg/hr. when procedure ends, infusion remimazolam stops and 0.9% normal saline or 0.2mg of flumazenil according to allocated groups.', 'armGroupLabels': ['group Control', 'group Flumazenil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05030', 'city': 'Seoul', 'state': "Seoul-T'ǔkpyǒlshi", 'country': 'South Korea', 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Seong-Hyop Kim, M.D. Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Konkuk University Medical Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konkuk University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yea-Ji Lee', 'investigatorAffiliation': 'Konkuk University Medical Center'}}}}