Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-07 @ 3:36 AM
Study NCT ID:
NCT03855267
Status:
UNKNOWN
Last Update Posted:
2019-02-26
First Post:
2019-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Etomidate/Propofol Mixture or Propofol Monotherapy Use in Patients Undergoing General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D005045', 'term': 'Etomidate'}], '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': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-25', 'studyFirstSubmitDate': '2019-02-24', 'studyFirstSubmitQcDate': '2019-02-25', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Recovery time', 'timeFrame': 'intraoperative', 'description': 'Anesthesia awakening time and extubation time'}], 'primaryOutcomes': [{'measure': 'blood pressure', 'timeFrame': 'intraoperative', 'description': 'the blood pressure is recorded (mmHg)'}, {'measure': 'heart rate', 'timeFrame': 'intraoperative', 'description': 'the heart rate is recorded(bpm)'}], 'secondaryOutcomes': [{'measure': 'Perioperative complications', 'timeFrame': 'intraoperative', 'description': 'the incidence of injection pain #nausea and vomit#intraoperative awareness and postoperative agitation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['propofol', 'etomidate', 'General anesthesia', 'mixture'], 'conditions': ['Etomidate is Mixed With Propofol']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate the effects of different proportions of etomidate/propofol mixture and propofol alone intravenous anesthesia on intraoperative and postoperative physiological indicators and complications, and to find out the optimal use ratio of E/P mixture.', 'detailedDescription': 'Propofol is one of the most commonly used intravenous anesthesia drugs clinically, the pharmacokinetic characteristics makes it very suitable for total intravenous anesthesia( TIVA), etomidate belongs to intravenous anesthesia with propofol, is a derivative of the imidazoles, its calm performance is strong, work quickly, no obvious respiratory depression, had little effects on the cardiovascular system, which, therefore, to protect the cardiovascular, maintain hemodynamic stability has a certain advantage. Our previous project showed that propofol and etomidate combined application can maintain stable hemodynamics in patients with better, reduce the occurrence of adverse reactions, can be used within 3 h of surgery anesthesia.The purpose of this study is to use propofol or etomidate/propofol mixture in combination with BIS monitoring to perform general anesthesia maintenance for patients, in order to ensure the appropriate depth of anesthesia, better maintain the hemodynamic stability of patients, reduce adverse reactions, and find the appropriate E/P mixture of the best proportion and dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients undergoing elective general anesthesia surgery in 3h;\n2. American Society of Anesthesiologists gradesâ… \\~III;\n3. Aged 18 to 65 years, Body Mass Index 18.5 \\~ 29.9kg / m2;\n4. Hemoglobin 100 \\~ 125g / L.\n5. In line with the ethics, the patients volunteered to take the test and signed the informed consent\n\nExclusion Criteria:\n\n1. Identify or suspect abuse or chronic use of narcotic sedatives and analgesics;\n2. Heart, or liver, or lung, or kidney dysfunction;\n3. Body mass index\\> 30kg / m2; or \\<18.5kg / m2\n4. Speech, hearing or mental disorders;\n5. severe diabetes, hyperkalemia ;\n6. participate in other drug clinical researches in four weeks;\n7. Poor compliance, can not complete clinical research by research program.\n8. Any cerebrovascular accident occurred within 3 months, such as stroke, TIA, etc\n9. Unstable angina and myocardial infarction occurred within 3 months;\n10. Having contraindications or allergies to experimental drugs and other narcotic drugs;\n11. Mental illness, hyperkalemia.'}, 'identificationModule': {'nctId': 'NCT03855267', 'briefTitle': 'Etomidate/Propofol Mixture or Propofol Monotherapy Use in Patients Undergoing General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University General Hospital'}, 'officialTitle': 'Effects of Etomidate/Propofol Mixture or Propofol Monotherapy With Different Proportions on Circulation and Prognosis in Patients Undergoing General Anesthesia', 'orgStudyIdInfo': {'id': 'GWang007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group A', 'description': 'Propofol 20 mg/ml, recommended anesthesia induction dose of 0.1\\~0.125 ml/kg, anesthesia maintenance pump speed of 0.2\\~0.5ml/kg/h. keep bispectral index within 40 # 60', 'interventionNames': ['Drug: Propofol 20 MG/ML']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GroupB', 'description': 'EP1:3, that is, 10ml etomidate was mixed with 30ml propofol, the recommended anesthesia induction dose was 0.1-0.125ml /kg, and the anesthesia maintenance pump speed was 0.2-0.5ml /kg/h.keep bispectral index within 40 # 60.Propofol 20 mg/ml,etomidate 2mg/ml.', 'interventionNames': ['Drug: Propofol 20 mg/ml , etomidate 2 mg/ml']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'EP1:1, that is, 20ml etomidate was mixed with 20ml propofol, the recommended anesthesia induction dose was 0.1-0.125ml /kg, and the anesthesia maintenance pump speed was 0.2-0.5ml /kg/h.keep bispectral index within 40 # 60.Propofol 20 mg/ml,etomidate 2mg/ml.', 'interventionNames': ['Drug: Propofol 20 mg/ml , etomidate 2 mg/ml']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group D', 'description': 'EP3:1, that is, 30ml etomidate was mixed with 10ml propofol, the recommended anesthesia induction dose was 0.1-0.125ml /kg, and the anesthesia maintenance pump speed was 0.2-0.5ml /kg/h.keep bispectral index within 40 # 60.Propofol 20 mg/ml,etomidate 2mg/ml.', 'interventionNames': ['Drug: Propofol 20 mg/ml , etomidate 2 mg/ml']}], 'interventions': [{'name': 'Propofol 20 MG/ML', 'type': 'DRUG', 'description': 'Pump propofol to keep bispectral index within 40 # 60', 'armGroupLabels': ['Group A']}, {'name': 'Propofol 20 mg/ml , etomidate 2 mg/ml', 'type': 'DRUG', 'description': 'Propofol was mixed with etomidate in different proportions.keep bispectral index within 40 # 60.', 'armGroupLabels': ['Group C', 'Group D', 'GroupB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300000', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zicheng wang, MM', 'role': 'CONTACT', 'email': '527640484@qq.com', 'phone': '13821112922'}], 'facility': 'Zicheng Wang', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Zicheng Wang, MM', 'role': 'CONTACT', 'email': '527640484@qq.com', 'phone': '13821112922'}], 'overallOfficials': [{'name': 'Guolin Wang, MD.PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tainjin Medical University General Hospita'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guolin Wang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Tianjin Medical University General Hospital', 'investigatorFullName': 'Guolin Wang', 'investigatorAffiliation': 'Tianjin Medical University General Hospital'}}}}