Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-03-07 @ 10:55 PM
Study NCT ID:
NCT02923128
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2016-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whether Dexmedetomidine Can Improve the Prognosis of Elderly Patients With Postoperative Cognitive Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}, {'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D017409', 'term': 'Sufentanil'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2016-09-11', 'studyFirstSubmitQcDate': '2016-10-03', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of postoperative delirium', 'timeFrame': '7 days after surgery', 'description': 'The four clinical criteria for CAM-ICU are as follows: (1) acute onset with fluctuating course of disease; (2) inattention; (3) altered level of consciousness; (4) disorganized thinking. Delirium can be diagnosed by the appearance of both features 1 and 2, with at least one of features 3 or 4.'}], 'secondaryOutcomes': [{'measure': 'NRS for pain', 'timeFrame': '3 days after surgery', 'description': 'Pain was assessed by NRS (Numeric Rating Scale) : assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".'}, {'measure': 'Adverse events', 'timeFrame': '3 days after surgery', 'description': 'including hypotension, hypertension, bradycardia, tachycardia, hypoxemia, and in-terventions (adjustment or stop study drug infusion or intravenous administration).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postoperative Cognitive Dysfunction', 'Postoperative Delirium']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether postoperative analgesia pump continuous infusion of dexmedetomidine are effective in the prevention of Postoperative delirium and Postoperative cognitive dysfunction.', 'detailedDescription': '1. collection of cases: This trail is approved by Hospital Ethics Committee, and patients who participated in the study signed the informed consent. The subject will select 300 elder patients (age ≥60 years) routine tumor surgery, American Society of Anesthesiologists classificationⅠ-Ⅲ. Preoperative liver and kidney function, blood electrolytes were in the normal range.\n2. Case group: Selected cases divided into the right dexmedetomidine group and control group by computer randomly, 150 patients in each group. Dexmedetomidine group (A group) analgesia pump formula is: 3 ug/kg sufentanil and 3 ug/kg dexmedetomi-dine, with 0.9% saline diluted to 150ml. Control group (group C) postoperative analgesia formula is: 3 ug/kg sufentanil, with 0.9% saline diluted to 150ml. Two group with the same anesthesia program.\n3. Our primary outcome was the 7-day incidence of postoperative delirium assessed by CAM-ICU twice daily (8 a.m. and 8 p.m.) and supplemented with a review of medical and nursing records. The assessment was carried out by investigators who had been trained prior to the trial and were unaware of the group assignment.All investigators and patients were unknown of experiments and results. The four clinical criteria for CAM-ICU are as follows: (1) acute onset with fluctuating course of disease; (2) inattention; (3) altered level of consciousness; (4) disorganized thinking. Delirium can be diagnosed by the appearance of both features 1 and 2, with at least one of features 3 or 4. RASS was used to measure sedation or agita-tion prior to testing delirium. If the patient was deeply sedated or unable to fall asleep (RASS - 4 or - 5), delirium assessment was halted; if RASS score was of - 3 or above, delirium was evaluated by CAM-ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients' age ≥60 years\n* Underwent elective non-cardiac surgery under general anesthesia\n\nExclusion Criteria:\n\n* Patients with severe bradycardia (heart rate\\<55bpm)\n* Severe arrhythmia or cardiac dysfunction (ejection fraction\\<35%)\n* Mini-Mental Scale Test (MMSE) Exclusion criteria: illiteracy \\<18, primary school \\<21, junior school and above \\<25\n* Preoperative clear systems and spiritual history of neurological disease or long-term use of sedatives or antidepressants\n* History of alcohol abuse or a history of drug dependence\n* Have brain surgery or trauma\n* Severe vision or hearing impairment\n* Cannot with the completion of tests of cognitive function\n* Refused to participate in the study"}, 'identificationModule': {'nctId': 'NCT02923128', 'briefTitle': 'Whether Dexmedetomidine Can Improve the Prognosis of Elderly Patients With Postoperative Cognitive Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': 'Whether Dexmedetomidine Can Improve the Prognosis of Elderly Patients With Postoperative Cognitive Dysfunction', 'orgStudyIdInfo': {'id': '2015-01-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine+routine PCIA', 'description': 'PCIA pump was provided after surgery, which consisted of 3 ug/kg sufentanil and 3 ug/kg dexmedetomidine, total amount 150ml, 2 mL bolus dose with a lock-out of 10 minutes and background infu-sion rate 2 mL/h.', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: Sufentanyl', 'Drug: Saline']}, {'type': 'SHAM_COMPARATOR', 'label': 'Routine PCIA', 'description': '3 ug/kg sufentanil without dexmedetomidine, total amount 150ml, 2 mL bolus dose with a lock-out of 10 minutes and background infu-sion rate 2 mL/h.', 'interventionNames': ['Drug: Sufentanyl', 'Drug: Saline']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Dexmedetomidine Hydrochloride Injection'], 'description': 'Dexmedetomidine 3 ug/kg is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed.', 'armGroupLabels': ['Dexmedetomidine+routine PCIA']}, {'name': 'Sufentanyl', 'type': 'DRUG', 'otherNames': ['Sufentanil Citrate Injection'], 'description': 'Sufentanyl 3 ug/kg is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed.', 'armGroupLabels': ['Dexmedetomidine+routine PCIA', 'Routine PCIA']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['normal saline,physiological saline,NS'], 'description': 'Saline is used to dilute other drugs', 'armGroupLabels': ['Dexmedetomidine+routine PCIA', 'Routine PCIA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Xie Kangjie', 'investigatorAffiliation': 'Zhejiang Cancer Hospital'}}}}