Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT06414018
Status:
COMPLETED
Last Update Posted:
2025-01-14
First Post:
2024-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Equivalent Dose of Alfentanil and Sufentanil in Bronchoscopic Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015760', 'term': 'Alfentanil'}, {'id': 'D017409', 'term': 'Sufentanil'}], 'ancestors': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-12', 'studyFirstSubmitDate': '2024-05-10', 'studyFirstSubmitQcDate': '2024-05-10', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'rate of Postoperative adverse reaction', 'timeFrame': '1 day', 'description': 'Airway obstruction, hypoxemia, apnea, laryngeal spasm, bronchospasm, cough, postoperative nausea and vomiting, postoperative pain (VAS score), hypotension, bradycardia, dizziness'}], 'primaryOutcomes': [{'measure': 'time of Recovery', 'timeFrame': '1day', 'description': 'the time from the end of surgery to awake of patient'}], 'secondaryOutcomes': [{'measure': 'Time records', 'timeFrame': '1 day', 'description': 'Anesthesia time, induction time, surgical time, awakening time and recovery time'}, {'measure': 'dose of drugs', 'timeFrame': '1 day', 'description': 'The total amount of sedative and analgesic drugs used.'}, {'measure': 'rate of respiratory suppression incidence', 'timeFrame': '1 day', 'description': 'Respiratory frequency\\<8 times/min or SP02\\<90%'}, {'measure': 'rate of Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '1day', 'description': "Intraoperative blood pressure and heart rate changes: record the patient's intraoperative blood pressure, heart rate, and the use of related vasoactive drugs; Postoperative adverse reactions: such as hypertension, hypotension, tachycardia, gastrointestinal symptoms, postoperative restlessness, etc"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Afentanil', 'sufentanil', 'bronchoscopy', 'Recovery time'], 'conditions': ['Effect of Drug']}, 'descriptionModule': {'briefSummary': 'The equivalent dose of sufentanil and afentanil combined with laryngeal mask was used for complex bronchoscopy to observe the intraoperative effect and the influence on the recovery of patients', 'detailedDescription': 'Afentanil is a powerful, fast-acting narcotic analgesic, which can effectively inhibit intubation reflex. Compared with sufentanil, it has a short half-life and is safer, and can be used as the first choice for short surgical analgesics. In this study, by comparing the use of equivalent dose sufentanil and afentanil combined with laryngeal mask for complex bronchoscopy, the intraoperative analgesic effect and the influence on the recovery of patients were observed, and a better anesthesia scheme was provided for tracheoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80,\n* ASA I-III level;\n* BMI 18.5\\~23.9;\n\nExclusion Criteria:\n\n* Patients with full stomach and high risk of reflux aspiration;\n* Allergic to benzodiazepines, opioids, rocuronium bromide;\n* Those who have taken sedative, analgesic or antidepressant drugs within 24 hours;\n* Pregnant and lactating women;\n* severe liver and kidney dysfunction;\n* Patients with severe anemia and hypoproteinemia;\n* Previous drug use history;\n* Recently participated in other clinical studies;\n* Patients who cannot cooperate with communication.'}, 'identificationModule': {'nctId': 'NCT06414018', 'acronym': 'EOEDSAAIBT', 'briefTitle': 'Effect of Equivalent Dose of Alfentanil and Sufentanil in Bronchoscopic Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Effect of Equivalent Dose of Alfentanil and Sufentanil Combined With Remimazolam in Complex Bronchoscopic Treatment', 'orgStudyIdInfo': {'id': 'EEDSA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sufentanil group', 'description': 'The dose of sufentanil group is 0.2μg/kg', 'interventionNames': ['Drug: Alfentanil']}, {'type': 'EXPERIMENTAL', 'label': 'Alfentanil', 'description': 'The dose of aifentanil group is 10μg/kg', 'interventionNames': ['Drug: Alfentanil']}], 'interventions': [{'name': 'Alfentanil', 'type': 'DRUG', 'otherNames': ['sufentanil'], 'description': 'alfentanil 10ug/kg is used for anesthesia induction', 'armGroupLabels': ['Alfentanil', 'Sufentanil group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430000', 'city': 'Hubei', 'state': 'Wuhan', 'country': 'China', 'facility': 'Aijun Xu', 'geoPoint': {'lat': 38.99842, 'lon': 112.01144}}], 'overallOfficials': [{'name': 'aijun xu, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'You can request it from the main researcher.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Xinxiang Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clincal doctor', 'investigatorFullName': 'aijun xu', 'investigatorAffiliation': 'Tongji Hospital'}}}}