Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-02-26 @ 1:26 PM
Study NCT ID:
NCT02142595
Status:
COMPLETED
Last Update Posted:
2015-09-24
First Post:
2014-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Sleep Quality of Patients Sedation With i.v. Dexmedetomidine or Midazolam Undergoing TURP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-22', 'studyFirstSubmitDate': '2014-05-15', 'studyFirstSubmitQcDate': '2014-05-19', 'lastUpdatePostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Change of postoperative sleep quality', 'timeFrame': 'preoperation, first postoperative night', 'description': 'The bispectral index score (BIS) was monitored during the operation and the first postoperative night'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dexmedetomidine', 'midazolam', 'sleep quality', 'delirium'], 'conditions': ['Sleep Quality of Patients Undergoing TURP']}, 'descriptionModule': {'briefSummary': 'The investigators designed a study to determine whether dexmedetomidine versus midazolam combined with spinal anesthesia would provide same postoperative sleep quality in patients undergoing transurethral prostatic resection.', 'detailedDescription': 'The investigators designed a study to determine whether dexmedetomidine versus midazolam combined with spinal anesthesia would provide same postoperative sleep quality in patients undergoing transurethral prostatic resection.The bispectral index score (BIS) was monitored during the operation and the first postoperative night'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants were deemed eligible if they were candidates for spinal anesthesia undergoing TURP\n\nExclusion Criteria:\n\n* The exclusion criteria were body mass index exceeding 30 kg/m2, preoperative Pittsburgh Sleep Quality Index global scores higher than 6, anesthesia time longer than 3 hours, allergy to drugs used in the study and treatment with sedatives and analgesics during the postoperative BIS-Vista monitoring period.'}, 'identificationModule': {'nctId': 'NCT02142595', 'briefTitle': 'Postoperative Sleep Quality of Patients Sedation With i.v. Dexmedetomidine or Midazolam Undergoing TURP', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University, China'}, 'officialTitle': 'Comparison of the Postoperative Sleep Quality of Patients Sedation With i.v. Dexmedetomidine or Midazolam Undergoing Transurethral Prostatic Resection(TURP)', 'orgStudyIdInfo': {'id': '20140515'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dexmeditomidine group D', 'description': 'The sedative solution was prepared as a 10µg /ml dexmedetomidine in an unlabeled 20ml syringe. The sedative solution administered intravenously started at rate of kg (weight of patient)\\*0.6 ml/h over a 10-min period and then at rate of kg (weight of patient)\\*0.15 ml/h through syringe pump to the end of surgery', 'interventionNames': ['Drug: dexmedetomidine']}, {'type': 'EXPERIMENTAL', 'label': 'Midazolam group M', 'description': 'The sedative solution was prepared as a 0.375mg/ml midazolam or normal saline in an unlabeled 20ml syringe. The sedative solution administered intravenously started at rate of kg (weight of patient)\\*0.6 ml/h over a 10-min period and then at rate of kg (weight of patient)\\*0.15 ml/h through syringe pump to the end of surgery', 'interventionNames': ['Drug: Midazolam']}, {'type': 'NO_INTERVENTION', 'label': 'group control', 'description': 'normal saline in an unlabeled 20ml syringe. The sedative solution administered intravenously started at rate of kg (weight of patient)\\*0.6 ml/h over a 10-min period and then at rate of kg (weight of patient)\\*0.15 ml/h through syringe pump to the end of surgery'}], 'interventions': [{'name': 'dexmedetomidine', 'type': 'DRUG', 'description': 'The sedative solution administered intravenously started at rate of kg (weight of patient)\\*0.6 ml/h over a 10-min period and then at rate of kg (weight of patient)\\*0.15 ml/h through syringe pump to the end of surgery', 'armGroupLabels': ['dexmeditomidine group D']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'The sedative solution administered intravenously started at rate of kg (weight of patient)\\*0.6 ml/h over a 10-min period and then at rate of kg (weight of patient)\\*0.15 ml/h through syringe pump to the end of surgery', 'armGroupLabels': ['Midazolam group M']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'the First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'overallOfficials': [{'name': 'Hong Ma, M.D.,PhD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesiology the first hospital of CMU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'the Anesthesiology Department', 'investigatorFullName': 'Wen-fei Tan', 'investigatorAffiliation': 'China Medical University, China'}}}}