Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-29 @ 12:32 PM
Study NCT ID:
NCT01283412
Status:
UNKNOWN
Last Update Posted:
2013-11-20
First Post:
2011-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine on Postoperative Delirium and Quality of Recovery in Geriatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}, {'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'lastUpdateSubmitDate': '2013-11-19', 'studyFirstSubmitDate': '2011-01-24', 'studyFirstSubmitQcDate': '2011-01-24', 'lastUpdatePostDateStruct': {'date': '2013-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative delirium', 'timeFrame': 'every 8 hours within 24 postoperative hours', 'description': 'Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours'}], 'secondaryOutcomes': [{'measure': 'Length of PACU stay', 'timeFrame': 'during PACU stay', 'description': 'Length of PACU stay (min)'}, {'measure': 'hemodynamic parameters', 'timeFrame': 'every 5min during operation and every 15min during PACU stay', 'description': 'Heart frequency, systolic blood pressure, diastolic blood pressure'}, {'measure': 'incidence of postoperative nausea and vomiting', 'timeFrame': '24 postoperative hours', 'description': 'incidence of postoperative nausea and vomiting'}, {'measure': 'quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS)', 'timeFrame': '24 postoperative hours', 'description': 'quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS)'}, {'measure': 'Postoperative delirium', 'timeFrame': '1st, 2nd, 3rd postoperative days', 'description': 'Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours'}, {'measure': 'Postoperative Stroke', 'timeFrame': '1st, 2nd, 3rd, 7th postoperative days', 'description': 'Postoperative Stroke will be determined by National Institute of Health stroke scale (NIHSS score).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Delirium', 'Dexmedetomidine', 'Adult Patients', 'Elective Major Surgery', 'General Anesthesia'], 'conditions': ['Delirium, Postoperative']}, 'descriptionModule': {'briefSummary': 'Postoperative agitation (hyperactive delirium) is common following major surgery(incidence was about 20% in our pilot study). Dexmedetomidine was related to a reduced delirium rate when comparing with midazolam in many clinical settings. It is not clear if dexmedetomidine is useful on reducing postoperative delirium. The hypothesis of present study: intraoperative application of dexmedetomidine (0.2ug/kg/h) is is effective (50% reduce) than placebo for reducing of early postoperative delirium and increase postoperative quality of recovery within 24 postoperative hours.', 'detailedDescription': "After approval from the Institute's Ethics Committee, this study was conducted at Tongji Hospital, a general university teaching hospital with 2500 beds in Wuhan, China.The study consisted of adult patients, American Society of Anaesthesiologists Physical Status (ASA-PS) I-III, undergoing selective major surgery under general anesthesia. All the patients were randomly assigned to receive dexmedetomidine or placebo during the operation. The primary outcome measure was postoperative delirium assessed by Nursing Delirium Screening Scale (Nu-DESC) every 8 hours within 24 postoperative hours. The secondary outcome was length of postanesthesia care unit (PACU) stay,postoperative hospital length of stay, hemodynamic parameters, the incidence of postoperative nausea and vomiting, and quality of recovery determined by quality of recovery (QOR40; maximum score 200)and Post-operative Quality Recovery Scale (PQRS) in the first 24 h after surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status class I-III\n* Aged 60 years or above\n* Elective major surgery under general anesthesia\n\nExclusion Criteria:\n\n* ASA-PS\\>=IV\n* Aged under 60 yr old\n* Body mass index (BMI) \\>30\n* Neurologic disease\n* Cardiac surgery and neurologic surgery\n* Anticonvulsant drugs\n* Chronic analgesics intake\n* Participating in the investigation of another study'}, 'identificationModule': {'nctId': 'NCT01283412', 'briefTitle': 'Dexmedetomidine on Postoperative Delirium and Quality of Recovery in Geriatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Intraoperative Application of Dexmedetomidine on the Incidence of Postoperative Delirium and Quality of Recovery in Geriatric Patients Undergoing Major Surgery', 'orgStudyIdInfo': {'id': 'TIHMZK02004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm P', 'description': 'Placebo infusion', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm D', 'description': 'Dexmedetomidine infusion', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (saline) iv. during the operation and stoped 30min before end of the surgery', 'armGroupLabels': ['Arm P']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Dexmedetomidine 0.1\\~0.2ug/kg/h iv. during the operation, and stoped 30min before end of surgery', 'armGroupLabels': ['Arm D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Mei, M.D.', 'role': 'CONTACT', 'email': 'wmei@tjh.tjmu.edu.cn', 'phone': '00862783663173'}, {'name': 'Yuke Tian, M.D.', 'role': 'CONTACT', 'email': 'yktian@tjh.tjmu.edu.cn', 'phone': '00862783663173'}, {'name': 'Wei Mei, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Wei Mei, M.D.', 'role': 'CONTACT', 'email': 'wmei@tjh.tjmu.edu.cn', 'phone': '00862783663173'}, {'name': 'Yuke Tian, M.D.', 'role': 'CONTACT', 'email': 'yktian@tjh.tjmu.edu.cn', 'phone': '00862783663173'}], 'overallOfficials': [{'name': 'Yuke Tian, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology'}, {'name': 'Chuanhan Zhang, MD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Wei Mei', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}