Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-02-02 @ 2:47 AM
Study NCT ID:
NCT02552459
Status:
UNKNOWN
Last Update Posted:
2016-10-18
First Post:
2015-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001165', 'term': 'Arteriovenous Malformations'}], 'ancestors': [{'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017409', 'term': 'Sufentanil'}], 'ancestors': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-16', 'studyFirstSubmitDate': '2015-05-26', 'studyFirstSubmitQcDate': '2015-09-16', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'dose of rescue tramadol', 'timeFrame': 'within the following 72 hours after surgery', 'description': 'measure the dose of tramadol using as rescue drug on post-operative 24h、48h、72h'}], 'primaryOutcomes': [{'measure': 'Pain on the VAS scale', 'timeFrame': 'within the following 72 hours after surgery', 'description': 'measure the VAS score at pre-operative day and post-operative 4h、8h、12h、24h、48h、72h。'}], 'secondaryOutcomes': [{'measure': 'blood pressure(BP)(mmHg)', 'timeFrame': 'within the following 72 hours after surgery', 'description': 'measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h'}, {'measure': 'heart rate(HR) (/min)', 'timeFrame': 'within the following 72 hours after surgery', 'description': 'measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h'}, {'measure': 'spO2(%)', 'timeFrame': 'within the following 72 hours after surgery', 'description': 'measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h'}, {'measure': 'breath(/min)', 'timeFrame': 'within the following 72 hours after surgery', 'description': 'measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h'}, {'measure': 'sedation level on ramsay sedation score', 'timeFrame': 'within the following 72 hours after surgery', 'description': 'measure sedation level using ramsay sedation score on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h'}, {'measure': 'vomit times', 'timeFrame': 'within the following 72 hours after surgery', 'description': 'measure vomit times on pre-operative day and at measure sedation level using ramsay sedation score on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h'}, {'measure': 'nausea', 'timeFrame': 'within the following 72 hours after surgery', 'description': 'measure whether nausea exists on pre-operative day and at measure sedation level using ramsay sedation score on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dexmedetomidine', 'patient controlled analgesia'], 'conditions': ['Arteriovenous Malformation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine effect of combined medication of sufentanil and dexmedetomidine in patient controlled analgesia after neurosurgery.', 'detailedDescription': 'Sufentanil is a classical drug for postoperative analgesia. Dexmedetomidine is a commonly used α2-adrenergic receptor, and it helps provide sedation, analgesia and inhibition of sympathetic activation. The investigators propose to recruit 120 patients who is undergoing the arteriovenous malformation embolism operation in department of Neurosurgery. Patients will be randomly divided into 4 groups(control group, sufentanil and low dexmedetomidine dose group, sufentanil and middle dexmedetomidine dose group, sufentanil and high dexmedetomidine dose group), then the investigators select post-operative records to determine whether dexmedetomidine can take a positive role in neurosurgical analgesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients undergoing venous malformation embolization operation through general anesthesia.\n2. aged 18-65 years old.\n3. operating time varies 1-4h,and extubation after the operation.\n\nExclusion Criteria:\n\n1. long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history.\n2. known for dexmedetomidine or other drugs allergy in this study.\n3. cannot communicate.\n4. preoperative systolic blood pressure \\<90 mmHg, or the heart rate \\<50/min.'}, 'identificationModule': {'nctId': 'NCT02552459', 'briefTitle': 'Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'FirstSunYetSen-jn2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'sufentanil', 'description': 'sufentanil 150μg，intravenous administration during the following 72 hours after operation.', 'interventionNames': ['Drug: Sufentanil']}, {'type': 'EXPERIMENTAL', 'label': 'sufentanil&dexmedetomidine 1', 'description': 'sufentanil 150μg，dexmedetomidine 0.05μg/kg/h，intravenous administration during the following 72 hours after operation.', 'interventionNames': ['Drug: Sufentanil', 'Drug: dexmedetomidine 1']}, {'type': 'EXPERIMENTAL', 'label': 'sufentani&dexmedetomidine 2', 'description': 'sufentanil 150μg，dexmedetomidine 0.1μg/kg/h，intravenous administration during the following 72 hours after operation.', 'interventionNames': ['Drug: Sufentanil', 'Drug: dexmedetomidine 2']}, {'type': 'EXPERIMENTAL', 'label': 'sufentanil&dexmedetomidine 3', 'description': 'sufentanil 150μg，dexmedetomidine 0.15μg/kg/h ，intravenous administration during the following 72 hours after operation.', 'interventionNames': ['Drug: Sufentanil', 'Drug: dexmedetomidine 3']}], 'interventions': [{'name': 'Sufentanil', 'type': 'DRUG', 'otherNames': ['Sufentanyl'], 'description': 'sufentanil 150μg， intravenous administration during post-operative 72 hours.', 'armGroupLabels': ['sufentani&dexmedetomidine 2', 'sufentanil', 'sufentanil&dexmedetomidine 1', 'sufentanil&dexmedetomidine 3']}, {'name': 'dexmedetomidine 1', 'type': 'DRUG', 'otherNames': ['Dex,Dexmedetomidine'], 'description': 'dexmedetomidine 0.05μg/kg/h, Continuous intravenous injection for 72 hours after operation', 'armGroupLabels': ['sufentanil&dexmedetomidine 1']}, {'name': 'dexmedetomidine 2', 'type': 'DRUG', 'otherNames': ['Dex,Dexmedetomidine'], 'description': 'dexmedetomidine 0.1μg/kg/h, Continuous intravenous injection for 72 hours after operation', 'armGroupLabels': ['sufentani&dexmedetomidine 2']}, {'name': 'dexmedetomidine 3', 'type': 'DRUG', 'otherNames': ['Dex,Dexmedetomidine'], 'description': 'dexmedetomidine 0.15μg/kg/h, Continuous intravenous injection for 72 hours after operation recorded in the following 72h.', 'armGroupLabels': ['sufentanil&dexmedetomidine 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Liu, Master', 'role': 'CONTACT', 'email': 'liuyisysu@126.com', 'phone': '+86 13632391455'}, {'name': 'Nan Jiang, professor', 'role': 'CONTACT', 'email': 'NJiang_sysu@126.com', 'phone': '+86 20 28823350'}], 'facility': 'the First Affiliated Hospital of Sun Yetsen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Liu Yi, master', 'role': 'CONTACT', 'email': 'liuyisysu@126.com', 'phone': '13632391455', 'phoneExt': '+86'}, {'name': 'Jiang nan, doctor', 'role': 'CONTACT', 'email': 'jiangnanshen@126.com', 'phone': '13725407606', 'phoneExt': '+86'}], 'overallOfficials': [{'name': 'Jiang Nan, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital, Sun Yat-sen Unniversity'}, {'name': 'Shao Xinxin, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital, Sun Yat-sen Unniversity'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident', 'investigatorFullName': 'Xinxin Shao', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}