Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-27 @ 7:12 PM
Study NCT ID:
NCT05724550
Status:
COMPLETED
Last Update Posted:
2025-04-08
First Post:
2023-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diaphragm Function After Reversal of Rocuronium-induced Neuromuscular Blockade With Sugammadex or Neostigmine in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055191', 'term': 'Delayed Emergence from Anesthesia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2023-01-15', 'studyFirstSubmitQcDate': '2023-02-09', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diaphragm excursion ratio', 'timeFrame': 'during diaphragm ultrasound procedure after reversal of neuromuscular blocking agent (T1), an average of 10 minute', 'description': 'The ratio of diaphragm excursion at the time before injecting neuromuscular blocking agent before surgery (T0) and diaphragm excursion at the time after reversal of neuromuscular blocking agent (T1)'}], 'secondaryOutcomes': [{'measure': 'modified lung ultrasound score before neuromuscular blockade (LUS_T0)', 'timeFrame': 'during lung ultrasound procedure before neuromuscular blocking agent (T0), an average of 10 minutes', 'description': 'Both lung ultrasound score can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss)'}, {'measure': 'modified lung ultrasound score after reversing neuromuscular blockade (LUS_T1)', 'timeFrame': 'during lung ultrasound procedure after reversing neuromuscular blocking agent(T1), an average of 10 minutes', 'description': 'Both lung ultrasound score can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss)'}, {'measure': 'modified lung ultrasound score at post-anesthesia care unit (PACU) (LUS_T2)', 'timeFrame': '30 minutes after entering the post-anesthesia care unit (T2)', 'description': 'Both lung ultrasound score can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss)'}, {'measure': 'total recovery time (sec)', 'timeFrame': 'From injection of neuromuscular block reversal agent to extubation, not to exceed 20 minutes', 'description': 'time from injection of a neuromuscular block reversal agent to extubation'}, {'measure': 'perioperative respiratory adverse events', 'timeFrame': 'intraoperative', 'description': 'laryngospasm, bronchospasm, desaturation (SpO2 \\< 95%), airway obstruction, severe coughing, postoperative stridor during the emergence period'}, {'measure': 'length of stay in post-anesthesia care unit', 'timeFrame': 'from entering the post-anesthesia care unit to discharge from the post-anesthesia care unit, up to 24 hours', 'description': 'Length of stay in post-anesthesia care unit'}, {'measure': 'Adverse events occurred during post-anesthesia care unit stay', 'timeFrame': 'from entering the post-anesthesia care unit to discharge from the post-anesthesia care unit, up to 24 hours', 'description': 'agitation, stridor, desaturation (SpO2\\<95%), nausea, vomiting, bradycardia, somnolence, need for oxygen support'}, {'measure': 'postoperative pulmonary complication', 'timeFrame': 'from entering the general ward after surgery to discharge from hospital, up to 7 days', 'description': 'pneumonia, respiratory failure, pleural effusion, atelectasis described in postoperative chest radiography, pneumothorax, bronchospasm, aspiration pneumonia'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuromuscular Block, Residual']}, 'referencesModule': {'references': [{'pmid': '40625141', 'type': 'DERIVED', 'citation': 'Park JB, Kim TW, Ji SH, Jang YE, Kim EH, Kim JT, Kim HS, Lee JH. Ultrasonographic assessment of sugammadex-enhanced early recovery of diaphragmatic function in children: A randomised double-blind controlled trial. Eur J Anaesthesiol. 2025 Oct 1;42(10):907-915. doi: 10.1097/EJA.0000000000002231. Epub 2025 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the recovery of diaphragm function and atelectasis after reversal of neuromuscular blockade with Neostigmine and Sugammadex using lung ultrasound and diaphragm ultrasound for children aged 2 to 7 who are scheduled for the surgical procedure under general anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between the ages of 2 and 7 who are scheduled for surgery lasting more than 1 hour under general anesthesia using a neuromuscular blocking agent\n\nExclusion Criteria:\n\n* Patients with a history of severe respiratory disease with a high risk of bronchoconstriction\n* Patients with abnormal findings on preoperative chest radiography such as severe atelectasis, pneumothorax, pleural effusion, or pneumonia.\n* Patients with severe renal or liver disease, or neuromuscular disease\n* Patients with a history of allergy to drugs (sugammadex, rocuronium neostigmine)\n* Patients with significant bradycardia\n* Patients scheduled for surgery where estimated blood loss during surgery is expected to be more than 30% of estimated blood volume, or cases where fluid imbalance is expected to be severe during surgery\n* patients scheduled for lung parenchyme/diaphragm/thoracic surgery\n* other researchers considered it inappropriate to participate in research.'}, 'identificationModule': {'nctId': 'NCT05724550', 'briefTitle': 'Diaphragm Function After Reversal of Rocuronium-induced Neuromuscular Blockade With Sugammadex or Neostigmine in Children', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Diaphragm and Lung Ultrasound After Reversal of Rocuronium-induced Neuromuscular Blockade With Sugammadex or Neostigmine in Children Undergoing Surgery : A Randomized Double-blind Controlled Trial', 'orgStudyIdInfo': {'id': 'H2212-027-1383'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Neostigmine', 'description': 'The use of neostigmine 0.02mg/kg for reversal of neuromuscular blocking agent.', 'interventionNames': ['Drug: Neostigmine']}, {'type': 'EXPERIMENTAL', 'label': 'Sugammadex', 'description': 'The use of sugammadex 2mg/kg for reversal of neuromuscular blocking agent.', 'interventionNames': ['Drug: Sugammadex']}], 'interventions': [{'name': 'Sugammadex', 'type': 'DRUG', 'otherNames': ['bridion'], 'description': '* Sugammadex(100mg/mL), 2mg/kg\n* After confirming Train-of-four counts 4, patients allocated to sugammadex group receive sugammadex 2mg/kg for reversal of rocuronium at the end of the surgery.', 'armGroupLabels': ['Sugammadex']}, {'name': 'Neostigmine', 'type': 'DRUG', 'otherNames': ['Neostigmine methylsulfate'], 'description': '* Neostigmine methylsulfate(0.5mg/mL) 0.02mg/kg\n* After confirming Train-of-four counts 4, patients allocated to neostigmine group receive neostigmine 0.02mg/kg (maximum 5mg) combined with atropine 0.02mg/kg for reversal of rocuronium at the end of the surgery.', 'armGroupLabels': ['Neostigmine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'state': 'Jongrogu', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Ji-Hyun Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}