Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:41 PM
Study NCT ID:
NCT05035069
Status:
UNKNOWN
Last Update Posted:
2021-09-05
First Post:
2021-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Ciprofol Compared to Propofol for Nonintubated General Anesthesia in Patients Undergoing TAVR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730795', 'term': '(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol'}, {'id': 'D015742', 'term': 'Propofol'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-02-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-01', 'studyFirstSubmitDate': '2021-08-27', 'studyFirstSubmitQcDate': '2021-09-01', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of time that BIS value is maintained between 40 and 60 (including boundary value)', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'Time from the start of drug infusion to the first BIS reduction to 60', 'timeFrame': 'Day 1'}, {'measure': 'Time from the end of drug infusion to the recovery of BIS to 90', 'timeFrame': 'Day 1'}, {'measure': 'Percentage of subjects received rescue treatment', 'timeFrame': 'Day 1'}, {'measure': 'Incidence of hypotension', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia, General']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the efficacy and safety of ciprofol compared to propofol for non-intubated general anesthesia in patients undergoing transcatheter aortic valve replacement (TAVR).', 'detailedDescription': 'This is a study in subjects undergoing transcatheter aortic valve replacement (TAVR). As designed, the study will include 1-day screening period, 1-day observation period, and 1-day safety follow-up. Participants will be randomly assigned to either experimental or control group with a 1:1 allocation, with 12 subjects in each group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient scheduled for TAVR through femoral artery access\n* 1h ≤ Expected duration of surgery ≤ 3h\n* Planned for general anesthesia without intubation\n* 18 ≤ BMI ≤ 30\n* ASA category Ⅱ～Ⅳ\n\nExclusion Criteria:\n\n* Contraindications to anesthesia/sedation or a history of adverse reaction to anesthesia/sedation\n* Known allergies to eggs, soy products, opioids and their antidotes, propofol, etc; Contraindications of propofol, opioids and their antidotes\n* Shock and hypotension difficult that is to be corrected by vasoactive drugs in the screening period\n* Hemoglobin (HB) \\< 10.0 g / dl (100 g / L)\n* Judged by the investigator to have any other factors that make the subject unsuitable for participation in the study.'}, 'identificationModule': {'nctId': 'NCT05035069', 'briefTitle': 'Efficacy and Safety of Ciprofol Compared to Propofol for Nonintubated General Anesthesia in Patients Undergoing TAVR', 'organization': {'class': 'INDUSTRY', 'fullName': 'Haisco Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Randomized, Single-Blinded, Parallel Single-Center Clinical Study Exploring the Efficacy and Safety of Ciprofol and Propofol for Nonintubated General Anesthesia in Patient Undergoing Transcatheter Aortic Valve Replacement (TAVR)', 'orgStudyIdInfo': {'id': 'HSK3486-IIT-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ciprofol', 'interventionNames': ['Drug: Ciprofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Ciprofol', 'type': 'DRUG', 'description': 'Ciprofol infusion, starting with 0.8 \\~ 1mg/kg/h until BIS value below 60 (including 60), and then 0.2 \\~ 0.6mg/kg/h until the end of the operation, ciprofol infusion was adjusted to keep the BIS value between 40-60.', 'armGroupLabels': ['Ciprofol']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'Propofol infusion, starting with 4 \\~ 5mg/kg/h until BIS value below 60 (including 60), and then 1 \\~ 3mg/kg/h until the end of the operation, propofol infusion was adjusted to keep the BIS value between 40-60.', 'armGroupLabels': ['Propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Min Yan, M.D.', 'role': 'CONTACT', 'email': 'zryanmin@zju.edu.cn'}], 'facility': 'Second Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Fangqiong Li', 'role': 'CONTACT', 'email': 'lifangq@haisco.com', 'phone': '+86 02867258840'}], 'overallOfficials': [{'name': 'Min Yan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Zhejiang University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haisco Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}