Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT05514405
Status:
RECRUITING
Last Update Posted:
2025-06-17
First Post:
2022-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Remimazolam and Propofol on Postoperative Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D005264', 'term': 'Femoral Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522201', 'term': 'remimazolam'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-14', 'studyFirstSubmitDate': '2022-08-23', 'studyFirstSubmitQcDate': '2022-08-23', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of delirium 3 days after the end of operation', 'timeFrame': 'Upto 3 days after surgery', 'description': 'delirium is evaluated preoperatively and 3 days after surgery using Mini-Mental State Examination'}], 'secondaryOutcomes': [{'measure': 'quality of recovery (QoR-15) 3 days after the end of the operation', 'timeFrame': 'Upto 3 days after surgery', 'description': 'QoR-15 survey is performed preoperatively and 3 days after surgery.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Fractures', 'Knee Osteoarthritis', 'Femur Fracture']}, 'descriptionModule': {'briefSummary': 'Remimazolam is an ultra-short acting benzodiazepine agonist which is used widely for general anesthesia and sedation. Remimazolam has several advantages. Remimazolam is rapidly metabolized by tissue esterase that it does not accumulate even after infusion for long periods of time. The presence of reversal agents (flumazenil) is also advantageous. Also, hemodynamic stability compared to propofol gives clinicians preference to use for geriatric anesthesia. However, the study on the effect of remimazolam compared to propofol on postoperative delirium have not been carried out. The purpose of the study is to compare the incidence of postoperative delirium and recovery profile in elderly patients undergoing orthopedic surgery using either remimazolam or propofol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elderly patients undergoing hip or knee arthroplasty under general anesthesia.\n* body mass index \\>30 kg/m2\n\nExclusion Criteria:\n\n* moderate to severe liver dysfunction\n* moderate to severe renal dysfunction\n* unable to extubate in the operation room after operation\n* benzodiazepine dependence\n* sensitivity to anesthetic drugs used for study (Benzodiazepines, Propofol, Remifentanil, Fentanyl citrate, Rocuronium bromide, Sugammadex, Flumazenil)\n* acute angle glaucoma\n* received (benzodiazepine, antianxiety drugs, antidepressant, antipsychotic drugs) within 24 hours.\n* acute psychotic depression\n* history stroke or cerebrovascular disease'}, 'identificationModule': {'nctId': 'NCT05514405', 'briefTitle': 'Effect of Remimazolam and Propofol on Postoperative Delirium', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'Effect of Remimazolam and Propofol on Postoperative Delirium in Elderly Patients Undergoing Hip and Knee Surgery', 'orgStudyIdInfo': {'id': '2022-03-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remimazolam group', 'description': 'Remimazolam is started during induction of anesthesia at the rate of 6 mg/kg/hr and continued at the rate of 1 mg/kg/hr (within 0.3-2 mg/kg/hr). Remimazolam is stopped 20 minutes before end of operation.', 'interventionNames': ['Drug: Remimazolam (Byfavo)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol group', 'description': 'Propofol is continuously infused within 1-5 μg/mL.', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Remimazolam (Byfavo)', 'type': 'DRUG', 'description': 'Remimazolam is continuously infused based on bispectral index (within 40-60).', 'armGroupLabels': ['Remimazolam group']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'Propofol is continuously infused based on bispectral index (within 40-60).', 'armGroupLabels': ['Propofol group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'In-Jung Jun', 'role': 'CONTACT', 'email': 'christine17@hanmail.net', 'phone': '82-10-9312-0162'}], 'facility': 'Sanggye Paik hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'In-Jung Jun, MD PhD', 'role': 'CONTACT', 'email': 'christine17@hanmail.net', 'phone': '82-10-9312-0162'}], 'overallOfficials': [{'name': 'In-Jung Jun, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Inje University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assisstant professor', 'investigatorFullName': 'In-Jung Jun', 'investigatorAffiliation': 'Inje University'}}}}