Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-03 @ 3:50 PM
Study NCT ID:
NCT06853067
Status:
COMPLETED
Last Update Posted:
2025-09-24
First Post:
2025-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dexmedetomidine and Remimazolam on Body Temperature in Patients Undergoing Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001832', 'term': 'Body Temperature Changes'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2025-02-18', 'studyFirstSubmitQcDate': '2025-02-24', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of hypothermia during surgery', 'timeFrame': 'Body temperature is monitored during surgery', 'description': 'Incidence of temperature \\<36℃ during spinal anesthesia is assessed.'}], 'secondaryOutcomes': [{'measure': 'Incidence of hypothermia in the post-anesthesia recovery room', 'timeFrame': 'Immediately after entering the the post-anesthesia recovery room, until the discharge', 'description': 'Body temperature is assessed in the in the post-anesthesia recovery room'}, {'measure': 'Incidence of shivering during surgery and in the post-anesthesia recovery room', 'timeFrame': 'During surgery and in the post-anesthesia recovery room', 'description': 'Occurrence of shivering is assessed.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Temperature Change, Body']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of dexmedetomidine and remimazolam on body temperature in patients undergoing spinal anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective surgery under spinal anesthesia\n\nExclusion Criteria:\n\n* Severe vascular disease\n* Thyroid dysfunction\n* Coagulopathy\n* Neuromuscular disease.'}, 'identificationModule': {'nctId': 'NCT06853067', 'briefTitle': 'Effect of Dexmedetomidine and Remimazolam on Body Temperature in Patients Undergoing Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'SMG-SNU Boramae Medical Center'}, 'officialTitle': 'Effect of Dexmedetomidine and Remimazolam on Body Temperature in Patients Undergoing Spinal Anesthesia', 'orgStudyIdInfo': {'id': '20240701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine group', 'description': 'Dexmedetomidine is administered for sedation in patients undergoing spinal anesthesia', 'interventionNames': ['Other: Monitoring of body temperature']}, {'type': 'EXPERIMENTAL', 'label': 'Remimazolam group', 'description': 'Remimazolam is administered for sedation in patients undergoing spinal anesthesia', 'interventionNames': ['Other: Monitoring of body temperature']}], 'interventions': [{'name': 'Monitoring of body temperature', 'type': 'OTHER', 'description': 'Body temperature is monitored in the forehead using the Temperature Monitoring Patient Sensors in patients sedated with dexmedetomidine or remimazolam during spinal anesthesia.', 'armGroupLabels': ['Dexmedetomidine group', 'Remimazolam group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07061', 'city': 'Seoul', 'state': 'Select State/Province', 'country': 'South Korea', 'facility': 'SMG-SNU Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD., PhD', 'investigatorFullName': 'Jin-Young Hwang', 'investigatorAffiliation': 'SMG-SNU Boramae Medical Center'}}}}