Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-06 @ 7:16 PM
Study NCT ID:
NCT06632067
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2024-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sugammadex and Time to Extubation in Ophthalmic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077122', 'term': 'Sugammadex'}, {'id': 'D009388', 'term': 'Neostigmine'}, {'id': 'D001285', 'term': 'Atropine'}], 'ancestors': [{'id': 'D047408', 'term': 'gamma-Cyclodextrins'}, {'id': 'D003505', 'term': 'Cyclodextrins'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003912', 'term': 'Dextrins'}, {'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D050338', 'term': 'Phenylammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 262}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-06', 'studyFirstSubmitDate': '2024-10-06', 'studyFirstSubmitQcDate': '2024-10-06', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time From reversal to extubation', 'timeFrame': 'Time From reversal to extubation', 'description': 'Time From reversal to extubation'}, {'measure': 'Time From the end of surgery to reversal', 'timeFrame': 'Time From the end of surgery to reversal', 'description': 'Time From the end of surgery to reversal'}], 'secondaryOutcomes': [{'measure': 'Time From induction to the end of surgery', 'timeFrame': 'Time From induction to the end of surgery', 'description': 'Time From induction to the end of surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sugammadex', 'general anesthesia', 'ophthalmologic surgical procedures'], 'conditions': ['General Anesthesia Using Endotracheal Intubation', 'Ophthalmologic Surgical Procedure', 'Sugammadex', 'Neostigmine', 'Extubation Readiness']}, 'descriptionModule': {'briefSummary': 'This study is to invastigate if patients treated with sugammadex compared to neostigmine/atropine would be extubate faster upon emergence of anesthesia.', 'detailedDescription': 'This is a retrospective case-control study including patients aged 18 years or older who underwent ophthalmic surgeries under general anesthesia with tracheal intubation between 2020 and 2022. Patients who received rocuronium as the sole neuromuscular blocking agent and were maintained with sevoflurane or desflurane and intravenous fentanyl were included. Based on the choice of reversal agent for neuromuscular blockade, patients were divided into two groups: the sugammadex group or the neostigmine group. Patients who underwent emergency surgery or combined surgeries with other specialties were excluded. Patient characteristics, including age, gender, ASA classification, weight, and height, were collected. Anesthesia-related medications were recorded. The time points of anesthesia induction, start and end of surgery, reversal agent administration, and tracheal extubation were documented.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study included patients aged 18 years or older who underwent ophthalmic surgeries under general anesthesia with tracheal intubation between 2020 and 2022. Patients who received rocuronium as the sole neuromuscular blocking agent and were maintained with sevoflurane or desflurane and intravenous fentanyl were included. Based on the choice of reversal agent for neuromuscular blockade, patients were divided into two groups: the sugammadex group or the neostigmine group. Patients who underwent emergency surgery or combined surgeries with other specialties were excluded.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\naged 18 years or older ophthalmic surgeries under general anesthesia with tracheal intubation between 2020 and 2022 received rocuronium as the sole neuromuscular blocking agent maintained with sevoflurane or desflurane and intravenous fentanyl\n\nExclusion Criteria:\n\nemergency surgery combined surgeries with other specialties'}, 'identificationModule': {'nctId': 'NCT06632067', 'briefTitle': 'Sugammadex and Time to Extubation in Ophthalmic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Comparison of Sugammadex and Neostigmine for Time to Extubation in Adult Patients Undergoing Routine Ophthalmic Surgery Under General Anesthesia', 'orgStudyIdInfo': {'id': 'CMUH112-REC3-124'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'sugammadex', 'description': 'those who use sugammadex for reversal of neuromuscular blockade', 'interventionNames': ['Drug: sugammadex']}, {'label': 'neostigmine', 'description': 'those who use neostigmine/atroping for reversal of neuromuscular blockade', 'interventionNames': ['Drug: Neostigmine + Atropine']}], 'interventions': [{'name': 'sugammadex', 'type': 'DRUG', 'description': 'sugammadex used for neuromuscular reversal', 'armGroupLabels': ['sugammadex']}, {'name': 'Neostigmine + Atropine', 'type': 'DRUG', 'description': 'Neostigmine and Atropine used for neuromuscular reversal', 'armGroupLabels': ['neostigmine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '404327', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Yi-Ying Chiang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Medical Univerity Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}