Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT05500703
Status:
COMPLETED
Last Update Posted:
2025-04-13
First Post:
2022-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2022-08-08', 'studyFirstSubmitQcDate': '2022-08-11', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'PONV', 'timeFrame': 'Day 7 postoperatively', 'description': 'modified postoperative nausea vomiting (PONV) score'}], 'primaryOutcomes': [{'measure': 'Measurement of analgesia relative brain regions assessed by BOLD under fMRI scanning', 'timeFrame': 'during operation', 'description': 'Measurement of analgesia relative brain regions inDexmedetomidine group (DEX group) and the Opioid group (OPI group) assessed by BOLD under fMRI scanning, and compare the two group different at the same time'}], 'secondaryOutcomes': [{'measure': 'Measurement of analgesia relative brain regions assessed by T1-MPRAGE under fMRI scanning', 'timeFrame': 'during operation', 'description': 'Measurement of analgesia relative brain regions inDexmedetomidine group (DEX group) and the Opioid group (OPI group) assessed by T1-MPRAGE under fMRI scanning, and compare the two group different at the same time'}, {'measure': 'Measurement of analgesia relative brain regions assessed by T2-SPACE under fMRI scanning', 'timeFrame': 'during operation', 'description': 'Measurement of analgesia relative brain regions inDexmedetomidine group (DEX group) and the Opioid group (OPI group) assessed by T2-SPACE under fMRI scanning, and compare the two group different at the same time'}, {'measure': 'systolic blood pressure (SBP)', 'timeFrame': 'during operation', 'description': 'hemodynamic change of the two groups included systolic blood pressure (SBP)'}, {'measure': 'diastolic blood pressure (DBP)', 'timeFrame': 'during operation', 'description': 'hemodynamic change of the two groups included diastolic blood pressure (DBP)'}, {'measure': 'mean arterial pressure (MAP)', 'timeFrame': 'during operation', 'description': 'hemodynamic change of the two groups included mean arterial pressure (MAP)'}, {'measure': 'heart rate (HR)', 'timeFrame': 'during operation', 'description': 'hemodynamic change of the two groups included heart rate (HR)'}, {'measure': 'NRS', 'timeFrame': 'Hour 4, Hour 12, Hour48 post-operatively', 'description': 'NRS immediately after operation at rest.(The p-NRS was an 11-point scale with 0 indicating no pain and 10 equaled worst possible pain)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepsy', 'Radiofrequency Ablation', 'Intracranial Surgery']}, 'descriptionModule': {'briefSummary': 'Background: Dexmedetomidine (Dex) is a highly selective 2-adrenergic receptor agonist with significant analgesia affection. This study is planned to explore the brain regions and functional neuronal network involved in promoting analgesia of Dexmedetomidine. Methods: Select 28 patients with the proposed intraoperative MR-guided radiofrequency ablation of epilepsy. The subjects were randomized into the Dexmedetomidine group (Dex group) (n=14) and the Placebo group (PO group) (n=14). DEX group: continuous intravenously administered 1.5 µg kg-1 h-1 dexmedetomidine 15min before anesthesia induction, continuous infusion for 15min after anesthesia induction, and then Intraoperative functional magnetic resonance imaging scanning was started. PO group: the equivalent administered speed 0.9% sodium chloride was continuously pumped for 15min before anesthesia induction, then induce and intraoperative fMRI scanning started after continuous 30min infusion. The intraoperative fMIR scan results were compared and analyzed to find the unique analgesic brain regions of DEX, and the differences of the functional neuronal network of analgesia effect between the two groups.', 'detailedDescription': 'Background: Dexmedetomidine (DEX) is a highly selective 2-adrenergic receptor agonist with significant analgesia affection. This study is planned to explore the brain regions and functional neuronal network involved in promoting analgesia of Dexmedetomidine. Methods: Select 12 patients with the proposed intraoperative MR-guided radiofrequency ablation of epilepsy. The subjects were randomized into the Dexmedetomidine group (DEX group) (n=14) and the Placebo group (PO group) (n=14). DEX group: continuous intravenously administered 1.5 µg kg-1 h-1 dexmedetomidine 15min before anesthesia induction, continuous infusion for 15min after anesthesia induction, and then Intraoperative functional magnetic resonance imaging scanning was started. OPI group: the equivalent administered speed 0.9% sodium chloride was continuously pumped for 15min before anesthesia induction, then induce and intraoperative fMRI scanning started after continuous 30min infusion. The intraoperative fMIR scan results were compared and analyzed to find the unique analgesic brain regions of DEX, and the differences of the functional neuronal network of analgesia effect between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of epilepsy and eligible for radiofrequency ablation\n2. 20-50 years old;\n3. American Society of Anesthesiologists rated (ASA) I-II\n4. body mass index (BMI)18.5\\~27.9 kg·m2.\n\nExclusion Criteria:\n\n1. pre-existing neuropsychiatric disorders;\n2. emergency surgery;\n3. coma;\n4. depression;\n5. cognitive impairment;\n6. implanted with metal devices.'}, 'identificationModule': {'nctId': 'NCT05500703', 'briefTitle': 'Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'China International Neuroscience Institution'}, 'officialTitle': 'Brain Regions and Functional Neuronal Network Characteristics of Dexmedetomidine Analgesia Under Intraoperative fMRI', 'orgStudyIdInfo': {'id': 'CINI-AD-20220706'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine group', 'description': '1.5 µg kg-1 h-1 dexmedetomidine', 'interventionNames': ['Drug: Dexmedetomidine Injectable Solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': '0.9% sodium chloride injection', 'interventionNames': ['Drug: Sodium Chloride 0.9% Inj']}], 'interventions': [{'name': 'Dexmedetomidine Injectable Solution', 'type': 'DRUG', 'otherNames': ['Dexmedetomidine'], 'description': 'continuous pump of 1.5ug / kg / h Dexmedetomidine 15min before anesthesia induction, continuous infusion for 30min after anesthesia induction, and then nuclear magnetic scanning was started.', 'armGroupLabels': ['Dexmedetomidine group']}, {'name': 'Sodium Chloride 0.9% Inj', 'type': 'DRUG', 'otherNames': ['only opioid and Sodium Chloride as placebo administration'], 'description': 'the equivalent Sodium Chloride 0.9% Inj was continuously pumped before anesthesia induction, induced by opioids for 15min, and intraoperative fMRI scanning was started after continuous infusion for 30min.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Xuanwu hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Xinya Wang, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'China International Neuroscience Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China International Neuroscience Institution', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}