Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-01-02 @ 9:16 AM
Study NCT ID:
NCT05354466
Status:
COMPLETED
Last Update Posted:
2024-09-20
First Post:
2022-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Respiratory Adverse events_sugammadex
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077122', 'term': 'Sugammadex'}, {'id': 'D009388', 'term': 'Neostigmine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-18', 'studyFirstSubmitDate': '2022-04-26', 'studyFirstSubmitQcDate': '2022-04-26', 'lastUpdatePostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative respiratory adverse events', 'timeFrame': 'from induction of anesthesia to end of operation, about 3 hours', 'description': 'the incidence of overall perioperative respiratory adverse events; oxygen desaturation \\< 95%, airway obstruction, laryngospasm, bronchospasm, severe coughing, or postoperative stridor'}], 'secondaryOutcomes': [{'measure': 'bradycardia', 'timeFrame': 'from induction of anesthesia to end of operation, about 3 hours', 'description': 'administration of IV atropine, glycopyrrolate, epinephrine, ephedrine'}, {'measure': 'Cardiac arrest', 'timeFrame': 'from induction of anesthesia to end of operation, about 3 hours', 'description': 'documented chest compressions/defibrillation/cardioversion'}, {'measure': 'Anaphylaxis', 'timeFrame': 'from induction of anesthesia to end of operation, about 3 hours', 'description': 'administration of epinephrine, methylprednisolone, diphenhydramine, documented diagnosis of anaphylactic/ anaphylatoid reaction'}, {'measure': 'Allergic reaction', 'timeFrame': 'from induction of anesthesia to end of operation, about 3 hours', 'description': 'redness, urticaria, wheeze'}, {'measure': 'Bronchospasm', 'timeFrame': 'from induction of anesthesia to end of operation, about 3 hours', 'description': 'administration of albuterol, epinephrine'}, {'measure': 'Nausea and vomiting', 'timeFrame': 'from induction of anesthesia to end of operation, about 3 hours'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Complication']}, 'descriptionModule': {'briefSummary': 'Perioperative respiratory adverse events are common in children. We aimed to evaluate the effect of sugammadex on the incidence of perioperative respiratory adverse events in pediatric patients receiving tonsillectomy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients aged 2-6 years who were scheduled for tonsillectomy under general anesthesia were enrolled\n\nExclusion Criteria:\n\n* a recent history of upper respiratory tract infection within 2 weeks of surgery\n* allergic reaction to sugammadex\n* renal failure\n* liver failure\n* arrhythmia'}, 'identificationModule': {'nctId': 'NCT05354466', 'briefTitle': 'Perioperative Respiratory Adverse events_sugammadex', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effect of Sugammadex Versus Neostigmine on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2203-061-1305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sugammadex as reversal agent', 'interventionNames': ['Drug: Sugammadex injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Neostigmine as reversal agent', 'interventionNames': ['Drug: Neostigmine']}], 'interventions': [{'name': 'Sugammadex injection', 'type': 'DRUG', 'description': 'sugammadex as reversal agent', 'armGroupLabels': ['Sugammadex as reversal agent']}, {'name': 'Neostigmine', 'type': 'DRUG', 'description': 'neostigmine as a reversal agent', 'armGroupLabels': ['Neostigmine as reversal agent']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul national university hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical associate professor', 'investigatorFullName': 'Eun-hee Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}