Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-04 @ 1:06 AM
Study NCT ID:
NCT05401058
Status:
UNKNOWN
Last Update Posted:
2023-01-23
First Post:
2022-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'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': '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': 'D004329', 'term': 'Droperidol'}, {'id': 'C007792', 'term': 'Fumigant 93'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2968}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-19', 'studyFirstSubmitDate': '2022-05-23', 'studyFirstSubmitQcDate': '2022-06-01', 'lastUpdatePostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of delirium within 7 days after operation', 'timeFrame': '7 days after operation', 'description': 'Incidence of delirium within 7 days after operation'}], 'secondaryOutcomes': [{'measure': 'Severity of delirium', 'timeFrame': 'From the end of operation to 7 days after opertation', 'description': 'Severity of Postoperative delirium'}, {'measure': 'Delirium-free days', 'timeFrame': 'From the end of operation to 7 days after opertation', 'description': 'Delirium-free days'}, {'measure': 'Postoperative hospital duration', 'timeFrame': 'From end of operation to discharge, an average of 1 week', 'description': 'Postoperative hospital duration'}, {'measure': 'cognitive function at 30 days and 6 months', 'timeFrame': '30 days and 6 months after surgery', 'description': 'cognitive function at 30 days and 6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['non-cardiac surgery', 'Droperidol', 'postoperative delirium', 'elderly patients'], 'conditions': ['Digestive System Disease', 'Urologic Diseases', 'Gynecological Disease', 'Orthopedic Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of this multicenter, prospective, randomized, double-blind and large sample study is to explore the preventive effect of low-dose droperidol on POD in elderly patients after non-cardiac surgery, providing new approach for reducing the incidence of POD and improving the prognosis and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age≥65 years\n* American Society of Anesthesiologists (ASA): I-III\n* Planning to undergo elective non-cardiac surgery under general anesthesia with endotracheal intubation, including digestive, orthopedic, urologic and gynecological surgery\n* Estimated operation time more than 2 hours\n* Not expected to be admitted to ICU postoperatively\n* Proficient in Chinese\n* Informed consent\n\nExclusion Criteria:\n\n* Morbid obesity with BMI \\>35 kg/m2;\n* History of psychological and neurological diseases, such as depression, schizophrenia, epilepsy, severe central nervous system depression, Parkinson's disease, Alzheimer's disease, myasthenia gravis, basal ganglia disease, etc;\n* Corrected QT (QTc) of electrocardiogram\\> 500ms;\n* Preoperative liver insufficiency (Child Pugh grade C);\n* End-stage renal disease requiring dialysis;\n* Severe heart failure \\[Metablic equivalent (METs)\\<4\\];\n* Allergic to droperidol;\n* Inability to communicate due to coma or dementia in preoperative period;\n* Preoperative delirium, assessed by 3D-CAM;\n* More than three standard alcoholic drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits);\n* Participating in conflicting clinical trials;\n* Expected to have an additional operation within 7 days after the index operation."}, 'identificationModule': {'nctId': 'NCT05401058', 'briefTitle': 'Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery: A Randomized, Double-blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'DECPOD-DP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Droperidol 1.25mg/0.5ml', 'interventionNames': ['Drug: Droperidol Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Normal saline 0.5ml', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Droperidol Injection', 'type': 'DRUG', 'otherNames': ['D'], 'description': 'About 30min before the end of operation, Droperidol 1.25mg/0.5ml will be administered by intravenous injection.', 'armGroupLabels': ['Experimental group']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['S'], 'description': 'About 30min before the end of operation, Normal saline 0.5ml will be administered by intravenous injection.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuesheng Liu, MD,PHD', 'role': 'CONTACT', 'email': 'liuxuesheng@ahmu.edu.cn', 'phone': '+8618655193385'}], 'facility': 'The first Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Zhengzhou', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiaqiang Zhang, MD,PHD', 'role': 'CONTACT', 'email': 'hnmzxh@163.com', 'phone': '+8613937121360'}], 'facility': 'Henan Provincial People Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '200127', 'city': 'Pudong', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Diansan Su, MD,PhD', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '+8618616514088'}], 'facility': 'Renji Hospital, Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.23995, 'lon': 121.50094}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Linzhong Zhang, PHD,MD', 'role': 'CONTACT'}], 'facility': 'Second hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Chengdu', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qian Lei, PHD,MD', 'role': 'CONTACT'}], 'facility': "Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital (SAMSPH)", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Chongqing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ke Wei, PhD,MD', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Diansan Su, MD,PHD', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '+8618616514088'}], 'overallOfficials': [{'name': 'Diansan Su, MD,PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Renji Hospital, Shanghai Jiaotong University, School of Medcine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}