Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-05 @ 8:01 AM
Study NCT ID:
NCT06425757
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2024-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Pharmacokinetics of Single Injection of Ciprofol in Patients With Moderate to Severe Hypoproteinemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007019', 'term': 'Hypoproteinemia'}], 'ancestors': [{'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730795', 'term': '(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2024-05-09', 'studyFirstSubmitQcDate': '2024-05-21', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood concentrations at different time points after a single injection', 'timeFrame': 'Before administration, after administration 0.5 minute, 1 minute, 2 minutes, 3 minutes, 5 minutes, 8 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours', 'description': 'Blood concentration of ciprofol'}], 'secondaryOutcomes': [{'measure': 'Onset time of ciprofol in patients with hypoproteinemia', 'timeFrame': 'Day 1', 'description': 'The time it takes for the blood concentration of a drug to reach the clinically active concentration level from zero'}, {'measure': 'Effect time of ciprofol in patients with hypoproteinemia', 'timeFrame': 'Day 1', 'description': 'From the time the drug was administered to the time the patient lost consciousness'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypoproteinemia', 'Pharmacokinetics', 'Ciprofol']}, 'descriptionModule': {'briefSummary': 'Blood concentrations of Ciprofol were measured at different time points after single injection in patients with hypoproteinemia', 'detailedDescription': 'This study was a single-center, interventional clinical study. Patients with different plasma albumin levels were selected before surgery and induced by a single injection of Ciprofol at a depth of 0.3 mg/kg. 2ml of venous blood was collected before and 0.5, 1, 2, 3, 5, 8, 15, 30min, 1h, 2h and 4h after administration. The pharmacokinetics of Ciprofol were studied by measuring the concentration of Ciprofol in blood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with moderate to severe hypoproteinemia (albumin \\< 30g/L, protein detection time uniformly within three days before surgery）\n* Weight greater than 45kg, BMI20-24\n* The ASA rating is Class I or Class II\n\nExclusion Criteria:\n\n* Severe liver dysfunction\n* Severe renal dysfunction\n* Patients with ASA grade III and above\n* Known allergy to eggs, soy products, opioids and their relief drugs, propofol\n* Emergency surgery'}, 'identificationModule': {'nctId': 'NCT06425757', 'briefTitle': 'Study on Pharmacokinetics of Single Injection of Ciprofol in Patients With Moderate to Severe Hypoproteinemia', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': 'Study on Pharmacokinetics of Single Injection of Ciprofol in Patients With Moderate to Severe Hypoproteinemia', 'orgStudyIdInfo': {'id': 'IRB-2024-315(IIT)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Severe Hypoproteinemia', 'description': 'Blood albumin concentration≤30g/L', 'interventionNames': ['Drug: ciprofol']}, {'type': 'OTHER', 'label': 'Moderate Hypoproteinemia', 'description': 'Blood albumin concentration 30g/L-40g/L', 'interventionNames': ['Drug: ciprofol']}, {'type': 'OTHER', 'label': 'Normal plasma albumin', 'description': 'Blood albumin concentration \\>40g/L', 'interventionNames': ['Drug: ciprofol']}], 'interventions': [{'name': 'ciprofol', 'type': 'DRUG', 'otherNames': ['Si Shuning'], 'description': 'Patients who intended to undergo elective surgery under general anesthesia were induced by a single intravenous injection of 0.3mg/kg and ciprofol, and the experimental drug was manually injected by CVC within 30s. 2ml of venous blood was collected before and after administration 0.5min, 1min, 2min, 3min, 5min, 8min, 15min 30min, 1h, 2h and 4h respectively. The concentration of cyclopofol in blood was measured', 'armGroupLabels': ['Moderate Hypoproteinemia', 'Normal plasma albumin', 'Severe Hypoproteinemia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejang', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'XIE Kangjie, doctoral', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zhejiang Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xie Kangjie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Xie Kangjie', 'investigatorAffiliation': 'Zhejiang Cancer Hospital'}}}}