Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-03-14 @ 12:33 PM
Study NCT ID:
NCT03841812
Status:
COMPLETED
Last Update Posted:
2020-10-14
First Post:
2019-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059226', 'term': 'Nociceptive Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-10', 'studyFirstSubmitDate': '2019-01-19', 'studyFirstSubmitQcDate': '2019-02-13', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'qNOX change', 'timeFrame': 'during operation', 'description': 'Nociception of index (qNOX) difference between two groups. The nociception index (NOX) derived from electroencephalogram (EEG) signals has been proposed as a noninvasive guide to indicate anesthesia depth. The neurological processing of noxious stimuli is defined as nociception. NOX ranges from 0-99, and the lower the index, the deeper the state of analgesia. NOX lower than 20 represents deep analgesia, and higher than 80 represents inadequate analgesia.'}], 'secondaryOutcomes': [{'measure': 'PACU duration', 'timeFrame': '24 hours', 'description': 'Post anesthesia care unit duration(PACU duration). The longer PACU duration indicate the worse situation of the patients'}, {'measure': 'PONV difference between two groups', 'timeFrame': '24 hours', 'description': 'postoperative nausea and vomiting ratio(PONV) difference between two groups. The more frequency of PONV, the worst comfortable outcome of the patients'}, {'measure': 'Post- operative pain difference between two groups', 'timeFrame': '24 hours', 'description': 'Post- operative pain difference between two groups using VAS(Visual analogue rating) Score evaluation. Pain was assessed 24 h post operation using a 0-10 numeric pain rating scale (VAS scale), where zero meant no pain and 10 meant the worst imaginable pain.VAS score (Post-operation 24 h) (0-1 VAS indicate None pain; 2-5 VAS indicate Moderate pain; 6-10 VAS indicate severe pain)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nociceptive Pain', 'Analgesic Adverse Reaction', 'Inhalant Use']}, 'descriptionModule': {'briefSummary': 'This study purpose to compare analgesia efficiency of propofol combine with sevoflurane with propofol only using index of Nociception (NOX)', 'detailedDescription': '1. Recently study found sevoflurane plays an important role through spinal nerve peptide receptor (NK.1R), glycine receptor (GlyR), neuron nicotinic receptor (nnAChRs), Methyl-1-methyl-1-day aspartate (NMDA receptor), and TRPV1 receptor (TRPV1 receptor) produce the analgesic efficiency.\n2. propofol was traditional sedation reagent.\n3. index of Nociception (NOX) was the objective index for analgesia This study purpose to compare analgesia efficiency of Only Propofol and sevoflurane combine with propofol using index of Nociception (NOX)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants were aged 18-65 years old,\n* American Society of Anesthesiologists (ASA) physical status I, II or III\n* scheduled to have urological surgery(would last longer than 1 h)\n* requiring general anesthesia.\n\nExclusion criteria:\n\n* refused to participate in this study;\n* Unable to communicate normally because of consciousness alterations;\n* a history of allergy to opioids\n* contraindications to inhalational anesthesia\n* a family history of malignant hyperthermia\n* a history of alcohol or drug abuse\n* received central nervous system-active drugs\n* super obese as defined by a body mass index ≥40 kg/m2\n* conditions liable to alter the pharmacokinetic and pharmacodynamic behaviors of the intravenous and inhalation anesthetics\n* previous head injury\n* neurologic\n* psychiatric disease\n* any disabling central nervous\n* cerebrovascular disease\n* using psychoactive\n* anti-convulsive medications at the time\n* unstable angina\n* manifested congestive heart failure\n* expected difficulty airway management'}, 'identificationModule': {'nctId': 'NCT03841812', 'briefTitle': 'Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol', 'organization': {'class': 'OTHER', 'fullName': 'China International Neuroscience Institution'}, 'officialTitle': 'Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol Using Index of Nociception (NOX)', 'orgStudyIdInfo': {'id': 'CINI-ZYLX-201809-50'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Propofol', 'description': '5mg/kg/h Propofol continue infusion during the maintain of anesthesia during the maintain of anesthesia.', 'interventionNames': ['Drug: 5mg/kg/h Propofol']}, {'type': 'EXPERIMENTAL', 'label': 'Propofol & Sevoflurane', 'description': '2mg/kg/h Propofol \\& 1% Sevoflurane group continue infusion(Balance anesthesia) during the maintain of anesthesia', 'interventionNames': ['Drug: Sevoflurane', 'Drug: 2 mg/kg/h Propofol']}], 'interventions': [{'name': '5mg/kg/h Propofol', 'type': 'DRUG', 'otherNames': ['5mg/kg/h Propofol Injection'], 'description': '5mg/kg/h Propofol continuously infused during intre-operation', 'armGroupLabels': ['Propofol']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['1% Sevoflurane'], 'description': '1% Sevoflurane continuously using during intre-operation.', 'armGroupLabels': ['Propofol & Sevoflurane']}, {'name': '2 mg/kg/h Propofol', 'type': 'DRUG', 'description': '2mg/kg/h Propofol continuously infused during intre-operation', 'armGroupLabels': ['Propofol & Sevoflurane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Xuanwu Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Ke Huang, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xuanwu Hospital, Beijing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China International Neuroscience Institution', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}