Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 11:06 PM
Study NCT ID:
NCT05760534
Status:
UNKNOWN
Last Update Posted:
2023-03-08
First Post:
2023-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ideal Dosage for Sedation of Obese Patients Undergoing Knee or Hip Arthroplasty Under Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C522201', 'term': 'remimazolam'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-26', 'studyFirstSubmitDate': '2023-02-26', 'studyFirstSubmitQcDate': '2023-02-26', 'lastUpdatePostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of intraoperative respiratory depression', 'timeFrame': 'From entrance to exit from the operating room', 'description': 'Incidence of intraoperative respiratory depression'}], 'secondaryOutcomes': [{'measure': 'Total remimazolam infusion dose', 'timeFrame': 'From start to end of remimazolam infusion', 'description': 'Total remimazolam infusion dose (mg/kg/h)'}, {'measure': 'Incidence of intraoperative hypotension', 'timeFrame': 'From entrance to exit from the operating room', 'description': 'Mean blood pressure \\<65 mmHg'}, {'measure': 'Incidence of intraoperative hypertension', 'timeFrame': 'From entrance to exit from the operating room', 'description': 'Systolic blood pressure \\>120% of baseline'}, {'measure': 'Incidence of intraoperative bradycardia', 'timeFrame': 'From entrance to exit from the operating room', 'description': 'Heart rate \\<45 bpm'}, {'measure': 'Incidence of intraoperative tachycardia', 'timeFrame': 'From entrance to exit from the operating room', 'description': 'Heart rate \\>120 bpm'}, {'measure': 'Incidence of intraoperative oxygen desaturation', 'timeFrame': 'From entrance to exit from the operating room', 'description': 'Pulse oximeter saturation (SpO2) \\< 93%'}, {'measure': 'Incidence of intraoperative nausea or vomiting', 'timeFrame': 'From entrance to exit from the operating room', 'description': 'Nausea or vomiting during surgery'}, {'measure': 'Incidence of intraoperative hiccups', 'timeFrame': 'From entrance to exit from the operating room', 'description': 'Hiccups during surgery'}, {'measure': 'Incidence of intraoperative paradoxical movements', 'timeFrame': 'From entrance to exit from the operating room', 'description': 'Paradoxical movements during surgery'}, {'measure': "Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score", 'timeFrame': 'From start of remimazolam infusion until time of full alertness', 'description': 'MOAA/S score assessment at 10 min intervals'}, {'measure': 'Intraoperative Patient State Index (PSi)', 'timeFrame': 'From entrance to exit from the operating room', 'description': 'Continuous monitoring of PSi with Sedline sensor'}, {'measure': 'Time to reach MOAA/S score 5 after end of surgery', 'timeFrame': 'From end of remimazolam infusion until time of full alertness', 'description': 'Time to reach MOAA/S score 5 (min)'}, {'measure': 'Length of stay at the post-anesthesia care unit (PACU)', 'timeFrame': 'From entrance to exit from the PACU', 'description': 'Length of stay at the PACU (min)'}, {'measure': 'Patient satisfaction', 'timeFrame': 'At exit from PACU', 'description': 'Numeric rating scale of 0 (not satisfied at all) to 10 (absolutely satisfied)'}, {'measure': 'Intraoperative recall', 'timeFrame': 'At exit from PACU', 'description': 'Assessment with the modified Brice questionnaire'}, {'measure': 'Incidence of postoperative nausea or vomiting', 'timeFrame': 'From entrance to exit from the PACU', 'description': 'Incidence of nausea or vomiting'}, {'measure': 'Incidence of postoperative delirium', 'timeFrame': 'From end of surgery to third postoperative day', 'description': 'Assessment with the Confusion Assessment Method (CAM)'}, {'measure': 'Incidence of postoperative respiratory depression', 'timeFrame': 'From entrance to exit from the PACU', 'description': 'Respiratory rate \\< 8/min or SpO2\\<93%'}, {'measure': 'Incidence of postoperative hypotension', 'timeFrame': 'From entrance to exit from the PACU', 'description': 'Mean blood pressure \\<65 mmHg'}, {'measure': 'Incidence of postoperative hypertension', 'timeFrame': 'From entrance to exit from the PACU', 'description': 'Systolic blood pressure \\>120% from baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthritis Knee', 'Arthritis Hip']}, 'descriptionModule': {'briefSummary': 'This study aims to compare ideal body weight- and total body weight-based dosage for remimazolam sedation of obese patients undergoing knee or hip arthroplasty under spinal anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective knee or hip arthroplasty under spinal anesthesia\n* BMI\\>25\n* American Society of Anesthesiologists (ASA) classification I, II, III\n\nExclusion Criteria:\n\n* Patient refusal\n* Contraindication for spinal anesthesia\n* Contraindication for remimazolam infusion\n* History of hypersensitivity to remimazolam\n* History of chronic use of benzodiazepine or opioid\n* Baseline MOAA/S score of 4 or lower\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05760534', 'briefTitle': 'Ideal Dosage for Sedation of Obese Patients Undergoing Knee or Hip Arthroplasty Under Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Ideal Dosage for Sedation of Obese Patients Undergoing Knee or Hip Arthroplasty Under Spinal Anesthesia - a Phase 4 Clinical Trial', 'orgStudyIdInfo': {'id': 'H-2301-016-1391'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ideal body weight group', 'interventionNames': ['Drug: Remimazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Total body weight group', 'interventionNames': ['Drug: Remimazolam']}], 'interventions': [{'name': 'Remimazolam', 'type': 'DRUG', 'description': '0.075 mg/kg Remimazolam will be loaded over 1 min, then continuously infused at 0.2-1.0 mg/kg/h based on ideal or total body weight', 'armGroupLabels': ['Ideal body weight group', 'Total body weight group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jin-Tae Kim, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'jintae73@gmail.com', 'phone': '+82-2-2072-2467'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}