Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-22 @ 8:33 AM
Study NCT ID:
NCT04027751
Status:
UNKNOWN
Last Update Posted:
2020-03-11
First Post:
2019-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'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': 'D000077526', 'term': 'Tropisetron'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1508}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2019-07-16', 'studyFirstSubmitQcDate': '2019-07-19', 'lastUpdatePostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of emergence delirium', 'timeFrame': 'Until the end of post-anesthesia care unit stay, assessed up to 1 hour', 'description': 'Screening of the patients regarding an emergence delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU). CAM-ICU is assessed at three different points of time:\n\n1. 15min after excubation\n2. 30min after excubation\n3. At discharge from post-anesthesia care unit (PACU)'}], 'secondaryOutcomes': [{'measure': 'Incidence of postoperative delirium', 'timeFrame': 'Within 3 days after surgery', 'description': 'Screening of the patients regarding a postoperative delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU)'}, {'measure': 'Incidence of postoperative nausea and vomiting', 'timeFrame': 'Within 3 days after surgery'}, {'measure': 'Postoperative Pain', 'timeFrame': 'Within 3 days after surgery', 'description': 'Visual Analogue Scale will be used to assess postoperative pain of patients. Numerical rating scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain.'}, {'measure': 'Length of Hospital stay', 'timeFrame': 'From the date of admission until discharged from hospital, up to 30 days'}, {'measure': 'Adverse events', 'timeFrame': 'Within 3 days after surgery', 'description': 'Other adverse events within 3 days after surgery were noted'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tropisetron', 'emergence delirium', 'postoperative delirium'], 'conditions': ['Emergence Delirium', 'Postoperative Delirium']}, 'referencesModule': {'references': [{'pmid': '33790560', 'type': 'DERIVED', 'citation': 'Huang X, Wu D, Wu AS, Wei CW, Gao JD. The Association of Insomnia with Depression and Anxiety Symptoms in Patients Undergoing Noncardiac Surgery. Neuropsychiatr Dis Treat. 2021 Mar 25;17:915-924. doi: 10.2147/NDT.S296986. eCollection 2021.'}, {'pmid': '33052400', 'type': 'DERIVED', 'citation': 'Sun Y, Lin D, Wang J, Geng M, Xue M, Lang Y, Cui L, Hao Y, Mu S, Wu D, Liang L, Wu A; Tropisetron and Delirium Group. Effect of Tropisetron on Prevention of Emergence Delirium in Patients After Noncardiac Surgery: A Trial Protocol. JAMA Netw Open. 2020 Oct 1;3(10):e2013443. doi: 10.1001/jamanetworkopen.2020.13443.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy and safety of Tropisetron in preventing emergence delirium.', 'detailedDescription': 'Delirium is a common complication during postoperative period, especially in elderly patients. The presence of postoperative delirium is independently associated with poor recovery, increased length of hospital stay, the development of long-term cognitive decline and increased mortality.\n\nTropisetron is a 5-HT3A receptor antagonist and is widely used to treat postoperative nausea and vomiting. Previous studies found that tropisetron has positive effect on cognitive function. This study aims to access the efficacy and safety of tropisetron in preventing emergence delirium.\n\nTo explore the results differences amongst different patients, subgroup analysis will be conducted according to: a. Age (older than 65 years versus 65 years or younger); b. Surgery type (major surgery versus minor surgery); c. Preoperative MoCA scores (\\>26 versus 18-26 versus 10-17).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written consent given\n2. Scheduled to undergo elective non-cardiac surgeries under general anesthesia\n3. ASA Physical Score I-III\n\nExclusion Criteria:\n\n1. Patients with a history of neurological disease, such as Alzheimer disease.\n2. Patients with a history of psychiatric disease\n3. Patients with a medication history of antipsychotic drugs over the last 30 days prior to enrollment.\n4. Unable to complete neuropsychological testing including patients with severe visual or hearing impairment.\n5. the Montreal Cognitive Assessment (MoCA) scores below 10\n6. Patients who have severe intraoperative adverse events, such as cardiac arrest.\n7. Patients with contraindication of tropisetron.'}, 'identificationModule': {'nctId': 'NCT04027751', 'briefTitle': 'The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '04719372'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tropisetron', 'description': 'Patients allocated to this arm will receive single dose of intravenous Tropisetron (5mg) before anesthesia induction.', 'interventionNames': ['Drug: Tropisetron']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients allocated to this arm will receive an identical volume of saline solution before anesthesia induction.', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Tropisetron', 'type': 'DRUG', 'description': 'Investigators administrated intravenously Tropisetron 5mg before anesthesia induction', 'armGroupLabels': ['Tropisetron']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Investigators administrated intravenously 0.9% saline solution as a placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Anshi Wu', 'role': 'CONTACT', 'email': 'wuanshi1965@163.com', 'phone': '+8685231330'}, {'name': 'Anshi Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Chaoyang Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Anesthesiology', 'investigatorFullName': 'Anshi Wu', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}