Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT06091904
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2023-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Sufentanil on the Intraoperative Hemodynamics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017409', 'term': 'Sufentanil'}, {'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2023-10-13', 'studyFirstSubmitQcDate': '2023-10-13', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative hypotension', 'timeFrame': 'During surgery', 'description': 'MAP \\< 80 mmHg'}], 'secondaryOutcomes': [{'measure': 'Inotropic requirements', 'timeFrame': 'During surgery', 'description': 'cumulative doses of inotropics during surgery'}, {'measure': 'Incidence of bradycardia', 'timeFrame': 'During surgery', 'description': 'heart rate \\< 40/min'}, {'measure': 'Incidence of tachycardia', 'timeFrame': 'During surgery', 'description': 'heart rate \\> 100/min'}, {'measure': 'Maximum systolic blood pressure', 'timeFrame': 'During surgery', 'description': 'maximal systolic blood pressure'}, {'measure': 'Minimum systolic blood pressure', 'timeFrame': 'During surgery', 'description': 'minimal systolic blood pressure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraoperative Hypotension']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, controlled trial. A total of 92 patients will be randomized to receive sufentanil or remifentanil during extracranial-intracranial bypass surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who undergo elective extracranial-intracranial bypass surgery\n* American Society of Anesthesiologists grade 1,2,3\n* Age \\> 18 years old\n\nExclusion Criteria:\n\n* Refuse to participate to the study\n* American Society of Anesthesiologists grade 4\n* Body Mass Index \\< 18.5 kg/m2 or \\> 35 kg/m2\n* Allergic history of opioid\n* pregnant\n* MAO Inhibitor user\n* Severe respiratory insufficiency'}, 'identificationModule': {'nctId': 'NCT06091904', 'briefTitle': 'Effects of Sufentanil on the Intraoperative Hemodynamics', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effects of Sufentanil on the Intraoperative Hemodynamic Parameters in Patients Undergoing Extracranial-intracranial Bypass Surgery: a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Bypass-SFTN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sufentanil group', 'description': 'sufentanil is administered for analgesic during general anesthesia', 'interventionNames': ['Drug: Sufentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'remifentanil group', 'description': 'remifentanil is administered for analgesic during general anesthesia', 'interventionNames': ['Drug: Remifentanil']}], 'interventions': [{'name': 'Sufentanil', 'type': 'DRUG', 'description': 'Induction: sufentanil TCI 0.3 ng/ml Maintenance: sufentanil TCI 0.05-0.5 ng/ml', 'armGroupLabels': ['sufentanil group']}, {'name': 'Remifentanil', 'type': 'DRUG', 'description': 'Induction: remifentanil TCI 3 ng/ml Maintenance: remifentanil TCI 0.5-5 ng/ml', 'armGroupLabels': ['remifentanil group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chang-Hoon Koo', 'role': 'CONTACT', 'email': 'vollock9@gmail.com'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Chang-Hoon Koo', 'role': 'CONTACT', 'email': 'vollock9@gmail.com', 'phone': '+821085098841'}], 'overallOfficials': [{'name': 'Chang-Hoon Koo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Chang-Hoon Koo', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}