Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-02-06 @ 5:53 PM
Study NCT ID:
NCT06382961
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2024-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Dexmedetomidine in Prevention of Postoperative Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D017409', 'term': 'Sufentanil'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 287}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2024-04-22', 'studyFirstSubmitQcDate': '2024-04-23', 'lastUpdatePostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of postoperative delirium', 'timeFrame': 'Delirium is assessed at 8 am and 8 pm for 3 days after surgery'}], 'secondaryOutcomes': [{'measure': 'Incidence of postoperative nausea and vomiting', 'timeFrame': 'Assessed twice a day for 7days after surgery'}, {'measure': 'incidence of postoperative complications', 'timeFrame': 'Assessed daily for 3 days after surgery', 'description': 'Other postoperative complications including including hypotension, hypertension, bradycardia, tachycardia, and hypoxemia'}, {'measure': 'Pain intensities', 'timeFrame': 'Assessed daily at 8 am for 3 days after surgery', 'description': 'patient pain assessed using numeric rating scale, ranged from 0 to 11, higher score indicate higher pain intensity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Delirium in Old Age', 'Anesthesia; Adverse Effect']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn how postoperative infusion of dexmedetomidine would influence postoperative delirium in elderly patients undergoing lung surgery. The main questions it aims to answer are :\n\n1. Does postoperative dexmedetomidine reduce the incidence of delirium after lung surgery?\n2. Does postoperative dexmedetomidine introduce other medical problems? Researchers will compare dexmedetomidine and sufentanil to see if dexmedetomidine works to reduce delirium.\n\nParticipants will undergo routine postoperative care:\n\n1. Patient-controlled self anesthesia with sufentanil only or combination of sufentanil and dexmedetomidine\n2. Postoperative visit twice a day for at least seven days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective surgery for lobectomy or segmentectomy\n\nExclusion Criteria:\n\n* local allergy to anesthetics;\n* patients with a clear preoperative history of nervous system and mental system diseases or long-term use of sedatives or antidepressants;\n* history of alcoholism, drug abuse or drug dependence;\n* have a history of brain surgery or injury;\n* epilepsy and associated mental and cognitive dysfunction, long-term stress stimulation, or psychological disorders;\n* sick sinus syndrome, second-degree or greater atrioventricular block or other contraindications for use of α2 adrenergic agonist;\n* liver and kidney insufficiency.'}, 'identificationModule': {'nctId': 'NCT06382961', 'briefTitle': 'Postoperative Dexmedetomidine in Prevention of Postoperative Delirium', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.'}, 'officialTitle': 'Postoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients Undergoing Lung Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SZUS_231101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experiment', 'interventionNames': ['Drug: Dexmedetomidine injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Drug: Sufentanil injection']}], 'interventions': [{'name': 'Dexmedetomidine injection', 'type': 'DRUG', 'description': 'Combining with 3 μg.kg-1 sufentanil, 3 μg.kg-1 dexmedetomidine is injected through intravenous patient controlled anesthesia pump in a 2 ml bolus with 20 minutes lock-out, and a background infusion rate of 2 ml per hour.', 'armGroupLabels': ['Experiment']}, {'name': 'Sufentanil injection', 'type': 'DRUG', 'description': '3 μg.kg-1 sufentanil is injected through intravenous patient controlled anesthesia pump in a 2 ml bolus with 20 minutes lock-out, and a background infusion rate of 2 ml per hour.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '650100', 'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': "Kunming Children's Hospital", 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}], 'overallOfficials': [{'name': 'Rui Zhao', 'role': 'STUDY_DIRECTOR', 'affiliation': "Department of Anesthesiology, Kunming Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Shenzhen People's Hospital", 'class': 'OTHER'}, {'name': "Dongyuan People's Hospital", 'class': 'UNKNOWN'}, {'name': "Kunming Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}