Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-31 @ 12:57 PM
Study NCT ID:
NCT05195034
Status:
RECRUITING
Last Update Posted:
2025-02-13
First Post:
2022-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'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': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, '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': 210}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2022-01-04', 'studyFirstSubmitQcDate': '2022-01-04', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of postoperative delirium.', 'timeFrame': 'postoperative 5 day.', 'description': 'postoperative delirium is assessed by the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) as applicable.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dexmedetomidine', 'Delirium', 'Awake Craniotomy']}, 'referencesModule': {'references': [{'pmid': '37743486', 'type': 'DERIVED', 'citation': 'Li M, Liu M, Cui Q, Zeng M, Li S, Zhang L, Peng Y. Effect of dexmedetomidine on postoperative delirium in patients undergoing awake craniotomies: study protocol of a randomized controlled trial. Trials. 2023 Sep 25;24(1):607. doi: 10.1186/s13063-023-07632-2.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative delirium (POD) is a common complication, and the incidence of POD ranges from 10% to 60%. Previous studies suggested that frontal approach and tumor located at the temporal lobe were independent risk factors for POD after supratentorial tumor resections. Therefore, patients undergoing awake craniotomies are high-risk populations for POD. A lot of trials show that dexmedetomidine might help to reduce the incidence of delirium in patients undergoing non-cardiac surgery. However, the impact of dexmedetomidine (DEX) on POD for patients undergoing awake craniotomies remains unclear. The purpose of this study was to investigate the effect of DEX on POD in patients undergoing awake craniotomies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing selective awake craniotomies.\n* Age ≥18 years.\n* Obtain written informed consent.\n\nExclusion Criteria:\n\n* 1.Preoperative moderate and severe cognitive impairment (Montreal Cognitive Assessment, MoCA\\< 18).\n* 2.Preoperative psychotropic medication within one year.\n* 3.BMI≤18 or ≥30 Kg/ m2\n* 4.Pregnant or lactating women.\n* 5.History of traumatic brain injury or neurosurgery.\n* 6.Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.\n* 7.Severe hepatic or renal dysfunction.'}, 'identificationModule': {'nctId': 'NCT05195034', 'briefTitle': 'Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Effect of Dexmedetomidine on Postoperative Delirium in Patients Undergoing Awake Craniotomies: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2022-01-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DEX group', 'description': 'The DEX group patients will be received dexmedetomidine intraoperatively.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'The placebo group patients will be received 0.9% saline intraoperatively.', 'interventionNames': ['Drug: 0.9% saline']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with continuous infusion at a rate of 0.2 µg/kg/hour until the end of dural closure.', 'armGroupLabels': ['DEX group']}, {'name': '0.9% saline', 'type': 'DRUG', 'description': 'The 0.9% saline is administered with the same volume at the same speed as the other group.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100160', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuming Peng', 'role': 'CONTACT', 'email': 'florapym766@163.com', 'phone': '8610-59976658'}], 'facility': 'Beijing Tian Tan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yuming Peng, MD,Ph.D', 'role': 'CONTACT', 'email': 'florapym766@163.com', 'phone': '8610-59976658'}], 'overallOfficials': [{'name': 'Yuming Peng, MD,Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tian Tan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy chief of Department of Anesthesiology', 'investigatorFullName': 'Yuming Peng', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}