Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-02-25 @ 11:48 PM
Study NCT ID:
NCT02845661
Status:
UNKNOWN
Last Update Posted:
2016-08-01
First Post:
2016-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation of Narcotrend Index and the Observer's Assessment of Alertness/Sedation (OAA/S) Scale
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-29', 'studyFirstSubmitDate': '2016-07-24', 'studyFirstSubmitQcDate': '2016-07-26', 'lastUpdatePostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the correlation coefficient between OAA/S scale and Narcotrend index in group 1', 'timeFrame': 'at 5-minute intervals until 30 minutes after administration', 'description': 'This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of 0.9 μg/kg dexmedetomidine intravenously.'}, {'measure': 'the correlation coefficient between OAA/S scale and Narcotrend index in group 2', 'timeFrame': 'at 5-minute intervals until 30 minutes after administration', 'description': 'This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of 1.0 μg/kg dexmedetomidine intravenously.'}, {'measure': 'the correlation coefficient between OAA/S scale and Narcotrend index in group 3', 'timeFrame': 'at 5-minute intervals until 30 minutes after administration', 'description': 'This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of 1.1 μg/kg dexmedetomidine intravenously.'}], 'secondaryOutcomes': [{'measure': 'The calculated cutoff values for OAA/S≤ 2', 'timeFrame': 'at 5-minute intervals until 30 minutes after administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Narcotrend index', 'OAA/S scale', 'Dexmedetomidine', 'Sedation'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Narcotrend index is a widely used quantitative parameter for evaluating anesthesia and sedation levels.Dexmedetomidine is a novel sedative,providing sedation while patients remain cooperative and can be easily aroused. This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of dexmedetomidine intravenously.', 'detailedDescription': "60 patients,aged 20～60,American Society of Anesthesiologists (ASA) physical status ⅠorⅡ, scheduled for electively lower limb surgery undergoing combined spinal epidural anesthesia were randomly divided three group. In each group,a bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia. The initial dose in group 1, group 2 and group 3 was started from 0.9 µg/kg,1.0 µg/kg and 1.1 µg/kg, respectively. HR、MAP、SpO2、the Observer's Assessment of Alertness/Sedation（OAA/S）scale and the corresponding Narcotrend index were recorded at 5-minute intervals until 30 minutes after administration. The relationship between OAA/S scale and Narcotrend index was analyzed by a Spearman analysis. The cutoff values of Narcotrend index for OAA/S≤2 were obtained by analysis of receiver operating characteristic curves(ROC)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ASA Ⅰ \\~ Ⅱ women undergoing Laparoscopic surgery.\n2. Written informed consent from the patient or the relatives of the participating patient.\n3. BMI:18.0～25 kg/m2\n\nExclusion Criteria:\n\n1. Mental illness can not match\n2. epidural anesthesia contraindicated\n3. People who have Slow-type arrhythmias\n4. Chronic renal failure\n5. Alcohol or drug abuse\n6. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug'}, 'identificationModule': {'nctId': 'NCT02845661', 'briefTitle': "Correlation of Narcotrend Index and the Observer's Assessment of Alertness/Sedation (OAA/S) Scale", 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou General Hospital of Guangzhou Military Command'}, 'officialTitle': 'The Correlation of Narcotrend Index and OAA/S Scale in Monitoring Sedation Level With Different Doses of Dexmedetomidine', 'orgStudyIdInfo': {'id': 'Narcotrend index'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group 1', 'description': 'patients in group 1, aged 20\\~60, were accepted an initial dose of 0.9μg/kg dexmedetomidine over 15 min.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'EXPERIMENTAL', 'label': 'group 2', 'description': 'patients in group 2, aged 20\\~60, were accepted an initial dose of 1.0μg/kg dexmedetomidine over 15 min.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'EXPERIMENTAL', 'label': 'group 3', 'description': 'patients in group 3, aged 20\\~60, were accepted an initial dose of 1.1μg/kg dexmedetomidine over 15 min.', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Dexmedetomidine 0.9 µg/kg'], 'description': 'a bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia,and the initial dose in group 1 was started from 0.9 µg/kg', 'armGroupLabels': ['group 1']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Dexmedetomidine 1.0 µg/kg'], 'description': 'a bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia,and the initial dose in group 2 was started from 1.0 µg/kg', 'armGroupLabels': ['group 2']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Dexmedetomidine 1.1 µg/kg'], 'description': 'a bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia,and the initial dose in group 3 was started from 1.1 µg/kg', 'armGroupLabels': ['group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510010', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yun Bi Chen', 'role': 'CONTACT', 'email': '645632618@qq.com', 'phone': '15622131984', 'phoneExt': '86'}, {'name': 'Yun Bi Chen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Guangzhou Military Region General Hospital, Department of Anesthesiology', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'bo Xu', 'role': 'CONTACT', 'email': 'xubo333@hotmail.com', 'phone': '88653387', 'phoneExt': '020'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou General Hospital of Guangzhou Military Command', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate chief physician', 'investigatorFullName': 'bo xu', 'investigatorAffiliation': 'Guangzhou General Hospital of Guangzhou Military Command'}}}}