Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:04 AM
Study NCT ID:
NCT07467603
Status:
COMPLETED
Last Update Posted:
2026-03-12
First Post:
2026-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ED50 of Remimazolam for Anesthesia Induction in Frail Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-08', 'studyFirstSubmitDate': '2026-03-01', 'studyFirstSubmitQcDate': '2026-03-08', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sedation Success (Loss of Consciousness)', 'timeFrame': 'up to 2 minutes', 'description': 'Defined as the achievement of Loss of Consciousness (LOC) confirmed by loss of eyelash reflex, no response to verbal commands, Ramsay Sedation Score ≥ 5, and MOAA/S score \\< 1.'}], 'secondaryOutcomes': [{'measure': 'Median Effective Dose (ED50) of Remimazolam', 'timeFrame': 'Perioperative/Periprocedural', 'description': 'The ED50 calculated via probit analysis based on the Dixon up-and-down sequential allocation method.'}, {'measure': 'Changes in Tidal Volume (VT)', 'timeFrame': 'Baseline, 30 seconds, 60 seconds, 90 seconds, and up to 120 seconds post-administration', 'description': 'Continuous assessment of spontaneous Tidal Volume (VT) utilizing a non-invasive Respiratory Volume Monitor (RVM) to evaluate subclinical respiratory depression.'}, {'measure': 'Mean Arterial Pressure (MAP)', 'timeFrame': 'Baseline and up to 2 minutes post-administration', 'description': 'Changes in Mean Arterial Pressure (MAP) during the induction period, measured in mmHg.'}, {'measure': 'Heart Rate (HR)', 'timeFrame': 'Baseline and up to 2 minutes post-administration', 'description': 'Changes in Heart Rate (HR) during the induction period, measured in beats per minute.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Remimazolam Tosilate', 'Frailty', 'Anesthesia Induction', 'Median Effective Dose (ED50)', 'Dixon Up-and-Down Method', 'Respiratory Volume Monitor (RVM)'], 'conditions': ['Frailty', 'Anesthesia Induction']}, 'descriptionModule': {'briefSummary': 'This study aimed to determine the median effective dose (ED50) of remimazolam for loss of consciousness (LOC) in elderly and frail elderly patients using the Dixon up-and-down method, while utilizing a novel Respiratory Volume Monitor (RVM) to detect subclinical respiratory depression.', 'detailedDescription': "The physiological decline associated with frailty in elderly patients presents significant challenges for anesthesia induction. Remimazolam tosilate, an ultra-short-acting benzodiazepine, offers a promising safety profile, yet its optimal dosing in frail populations remains undefined. This prospective, up-and-down sequential allocation trial was conducted at the Second Hospital of Hebei Medical University. 58 patients aged ≥65 years undergoing elective surgery were stratified into two groups: an Elderly Group (Clinical Frailty Scale \\[CFS\\] \\< 5) and a Frail Elderly Group (CFS ≥ 5). The initial remimazolam induction dose was set at 0.15 mg/kg for the elderly group and 0.13 mg/kg for the frail group, with dose adjustments based on the previous patient's response. A non-invasive RVM was employed to continuously monitor Tidal Volume (VT) and detect early hypoventilation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥65 years;\n* Scheduled for elective surgery under general anesthesia with endotracheal intubation;\n* American Society of Anesthesiologists (ASA) physical status II or III;\n* Body Mass Index (BMI) between 18 and 30 kg/m².\n\nExclusion Criteria:\n\n* Known allergy to benzodiazepines;\n* History of severe respiratory or cardiovascular disease (e.g., acute heart failure, severe COPD);\n* Long-term use of sedatives, analgesics, or alcohol abuse;\n* Known neuromuscular disorders (e.g., myasthenia gravis);\n* Inability to communicate for sedation assessment.'}, 'identificationModule': {'nctId': 'NCT07467603', 'briefTitle': 'ED50 of Remimazolam for Anesthesia Induction in Frail Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Hebei Medical University'}, 'officialTitle': 'Significantly Reduced Median Effective Dose (ED50) of Remimazolam for Anesthesia Induction in Frail Elderly Patients: A Prospective Dose-Finding Clinical Trial With Respiratory Volume Monitoring', 'orgStudyIdInfo': {'id': '2025-R031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Elderly Group (Non-Frail)', 'description': 'Patients with a Clinical Frailty Scale (CFS) score \\< 5.', 'interventionNames': ['Drug: Remimazolam Tosilate']}, {'type': 'EXPERIMENTAL', 'label': 'Frail Elderly Group', 'description': 'Patients with a Clinical Frailty Scale (CFS) score ≥ 5.', 'interventionNames': ['Drug: Remimazolam Tosilate']}], 'interventions': [{'name': 'Remimazolam Tosilate', 'type': 'DRUG', 'description': 'The initial induction dose was set at 0.15 mg/kg administered as a single intravenous bolus over 30 seconds. The dose adjustment gradient for consecutive patients was 0.02 mg/kg based on the Dixon up-and-down method.', 'armGroupLabels': ['Elderly Group (Non-Frail)']}, {'name': 'Remimazolam Tosilate', 'type': 'DRUG', 'description': 'The initial induction dose was set at 0.13 mg/kg administered as a single intravenous bolus over 30 seconds. The dose adjustment gradient for consecutive patients was 0.01 mg/kg based on the Dixon up-and-down method.', 'armGroupLabels': ['Frail Elderly Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Second Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Hebei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Yanjie Yang', 'investigatorAffiliation': 'The First Hospital of Hebei Medical University'}}}}