Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-01-08 @ 8:02 AM
Study NCT ID:
NCT03355534
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2017-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine Improves Recovery After Cranial Aneurysm Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'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': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-25', 'studyFirstSubmitDate': '2017-11-19', 'studyFirstSubmitQcDate': '2017-11-22', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of coughing', 'timeFrame': 'from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes'}], 'secondaryOutcomes': [{'measure': "Ricker's agitation-sedation score", 'timeFrame': 'from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes'}, {'measure': 'score of coughing', 'timeFrame': 'from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes', 'description': '0=no coughing;1=intermittent coughing;2=continuous coughing'}, {'measure': 'time to response to verbal command', 'timeFrame': 'from end of infusing anesthetics to response to verbal command,averagely 20 minutes'}, {'measure': 'time to extubation', 'timeFrame': 'from end of infusing anesthetics to extubation,averagely 28 minutes'}, {'measure': 'blood pressure before and after extubation', 'timeFrame': 'from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes'}, {'measure': 'blood glucose before and after aneurysm embolism', 'timeFrame': 'immediately before inserting coil and after finishing inserting coil,an average of 1 hour'}, {'measure': 'blood lactate before and after aneurysm embolism', 'timeFrame': 'immediately before inserting coil and after finishing inserting coil,,an average of 1 hour'}, {'measure': 'Mini-mental state examination score', 'timeFrame': '24 hours after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dexmedetomidine', 'general anesthesia', 'cerebral aneurysm'], 'conditions': ['Aneurysm Cerebral']}, 'referencesModule': {'references': [{'pmid': '24974190', 'type': 'RESULT', 'citation': 'Peng K, Wu S, Liu H, Ji F. Dexmedetomidine as an anesthetic adjuvant for intracranial procedures: meta-analysis of randomized controlled trials. J Clin Neurosci. 2014 Nov;21(11):1951-8. doi: 10.1016/j.jocn.2014.02.023. Epub 2014 Jun 25.'}, {'pmid': '21991729', 'type': 'RESULT', 'citation': 'Soliman RN, Hassan AR, Rashwan AM, Omar AM. Prospective, randomized controlled study to assess the role of dexmedetomidine in patients with supratentorial tumors undergoing craniotomy under general anesthesia. Middle East J Anaesthesiol. 2011 Feb;21(1):23-33.'}, {'pmid': '28631453', 'type': 'RESULT', 'citation': 'Elbakry AE, Ibrahim E. Propofol-dexmedetomidine versus propofol-remifentanil conscious sedation for awake craniotomy during epilepsy surgery. Minerva Anestesiol. 2017 Dec;83(12):1248-1254. doi: 10.23736/S0375-9393.17.11873-0. Epub 2017 Jun 14.'}, {'pmid': '28639236', 'type': 'RESULT', 'citation': 'Jun JH, Kim KN, Kim JY, Song SM. The effects of intranasal dexmedetomidine premedication in children: a systematic review and meta-analysis. Can J Anaesth. 2017 Sep;64(9):947-961. doi: 10.1007/s12630-017-0917-x. Epub 2017 Jun 21.'}, {'pmid': '28470100', 'type': 'RESULT', 'citation': 'Sun Y, Li Y, Sun Y, Wang X, Ye H, Yuan X. Dexmedetomidine Effect on Emergence Agitation and Delirium in Children Undergoing Laparoscopic Hernia Repair: a Preliminary Study. J Int Med Res. 2017 Jun;45(3):973-983. doi: 10.1177/0300060517699467. Epub 2017 Mar 21.'}]}, 'descriptionModule': {'briefSummary': 'Dexmedetomidine induces analgesic and sedative effects and is reported to decrease agitation during emergence after general anesthesia in various surgeries. For patients undergoing cranial aneurysm surgeries, a calm anesthesia and emergence is important. In this study, the investigatorstend to observe the effect of dexmedetomidine on maintenance and recovery of patients undergoing cranial aneurysm surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing cerebral aneurysm embolism under general anesthesia\n\nExclusion Criteria:\n\n* patients with bradycardia or atrioventricular heart block\n* patients with ASA(American Society of Anesthesiologists) status over 3\n* patients with body mass index(BMI)≥30kg/m2\n* patients with difficulty in communication\n* patients with ruptured aneurysm\n* patients suspected or proved to be pregnant'}, 'identificationModule': {'nctId': 'NCT03355534', 'acronym': 'DACA', 'briefTitle': 'Dexmedetomidine Improves Recovery After Cranial Aneurysm Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Effect of Dexmedetomidine on Maintenance and Recovery of Cranial Aneurysm Surgery', 'orgStudyIdInfo': {'id': 'XJH-A-2017-10-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nasal dexmedetomidine', 'description': 'dexmedetomidine is given nasally, saline is given intravenously', 'interventionNames': ['Drug: nasal dexmedetomidine', 'Drug: intravenous saline']}, {'type': 'EXPERIMENTAL', 'label': 'intravenous dexmedetomidine', 'description': 'saline is given nasally, dexmedetomidine is given intravenously', 'interventionNames': ['Drug: Intravenous dexmedetomidine', 'Drug: nasal saline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'normal saline', 'description': 'saline is given nasally and intravenously', 'interventionNames': ['Drug: intravenous saline', 'Drug: nasal saline']}], 'interventions': [{'name': 'Intravenous dexmedetomidine', 'type': 'DRUG', 'description': 'drug is intravenously infused to patients', 'armGroupLabels': ['intravenous dexmedetomidine']}, {'name': 'nasal dexmedetomidine', 'type': 'DRUG', 'description': 'drug is nasally given to patients', 'armGroupLabels': ['nasal dexmedetomidine']}, {'name': 'intravenous saline', 'type': 'DRUG', 'description': 'saline is given to patients intravenously', 'armGroupLabels': ['nasal dexmedetomidine', 'normal saline']}, {'name': 'nasal saline', 'type': 'DRUG', 'description': 'normal saline is given to patients nasally', 'armGroupLabels': ['intravenous dexmedetomidine', 'normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Lize Xiong', 'role': 'STUDY_CHAIR', 'affiliation': 'Air Force Military Medical University, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhihong LU', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'Zhihong LU', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}