Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT03487003
Status:
COMPLETED
Last Update Posted:
2019-10-25
First Post:
2018-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Muscle Relaxants on Efficacy of LMA Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009123', 'term': 'Muscle Hypotonia'}], 'ancestors': [{'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized parallel prospective non-inferiority study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-24', 'studyFirstSubmitDate': '2018-03-15', 'studyFirstSubmitQcDate': '2018-03-27', 'lastUpdatePostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oropharyngeal leak pressure (OLP)', 'timeFrame': 'During 1 min after successful LMA intubation', 'description': 'It was determined by the method describe by Lopez-Gil and colleagues. Briefly, it was measured by closing the expiratory valve of the circle system at a fixed gas flow of 3l/min, recording the airway pressure at which audible leak sound was heard.'}], 'secondaryOutcomes': [{'measure': 'Intubation time', 'timeFrame': 'During 5-10 min after inhalation of sevoflurane', 'description': 'from the time of mouth opening until the time at square-wave capnography was detected'}, {'measure': 'Ease of intubation/mask bagging', 'timeFrame': 'During 5-10 min after inhalation of sevoflurane', 'description': 'After successful LMA insertion, investigator recorded subjective difficulty during whole period of LMA manipulation by Likert scale: 1, easy 2, moderate, and 3: difficult.'}, {'measure': 'Fiberoptic view of LMA', 'timeFrame': 'During 5min after successful LMA insertion', 'description': 'The fibreoptic view was assessed by fibreoptic bronchoscopy through the LMA and graded.'}, {'measure': 'Mean blood pressure', 'timeFrame': 'During 5-10 min after inhalation of sevoflurane', 'description': 'mean blood pressure (mmHg) is recorded before and after the insertion of LMA.'}, {'measure': 'Heart rate', 'timeFrame': 'During 5-10 min after inhalation of sevoflurane', 'description': 'Heart rate is (beat per minutes) recorded before and after the insertion of LMA.'}, {'measure': 'Watcha scale every 10 min from time to PACU admission to discharge', 'timeFrame': 'During 60 minutes after PACU admission', 'description': 'On arrival and every 10 min after PACU admission, patients were checked Watcha scale as following 4-point scale\n\n1. calm\n2. crying, but can be consoled\n3. Crying, cannot be consoled\n4. Agitated and thrashing around'}, {'measure': 'FLACC score on initial, 10, 20, and 30 min', 'timeFrame': 'During 60 minutes after PACU admission', 'description': 'Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission'}, {'measure': 'Eye opening time', 'timeFrame': 'During 1 hour after operation', 'description': 'defined as the interval from the cessation of anesthetics to eye opening'}, {'measure': 'Extubation time', 'timeFrame': 'During 1 hour after operation', 'description': 'time from discontinuation of anesthetics to extubation'}, {'measure': 'Peak inspiratory pressure before and after the surgery', 'timeFrame': 'During 4 hour after anesthetic inhalation', 'description': 'check the peak inspiratory pressure (cmH2O) before and at the end of surgery'}, {'measure': 'Tidal volume ratio before and after the surgery', 'timeFrame': 'During 4 hour after anesthetic inhalation', 'description': 'check the expiratory tidal volume/setting tidal volume ratio before and at the end of surgery'}, {'measure': 'Respiratory adverse events', 'timeFrame': 'During 1 hour after operation', 'description': 'check the adverse events during emergence and PACU stay such as coughing, laryngospasm, bronchospasm, postoperative stridor and mild desaturation; SpO2 \\<95%.'}, {'measure': 'Postoperative complications', 'timeFrame': 'During 1 hour after operation', 'description': 'check the adverse events including respiratory adverse events, gastric insufflation, excessive secretion, postoperative nausea and vomiting, sore throat, and tinged blood on LMA surface.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laryngeal mask airway', 'children, preschool', 'muscle relaxant'], 'conditions': ['Anesthesia Intubation Complication']}, 'referencesModule': {'references': [{'pmid': '26550303', 'type': 'BACKGROUND', 'citation': 'Gong YH, Yi J, Zhang Q, Xu L. Effect of low dose rocuronium in preventing ventilation leak for flexible laryngeal mask airway during radical mastectomy. Int J Clin Exp Med. 2015 Aug 15;8(8):13616-21. eCollection 2015.'}, {'pmid': '20816545', 'type': 'BACKGROUND', 'citation': 'von Ungern-Sternberg BS, Boda K, Chambers NA, Rebmann C, Johnson C, Sly PD, Habre W. Risk assessment for respiratory complications in paediatric anaesthesia: a prospective cohort study. Lancet. 2010 Sep 4;376(9743):773-83. doi: 10.1016/S0140-6736(10)61193-2.'}, {'pmid': '19434792', 'type': 'BACKGROUND', 'citation': 'Ghai B, Wig J. Comparison of different techniques of laryngeal mask placement in children. Curr Opin Anaesthesiol. 2009 Jun;22(3):400-4. doi: 10.1097/aco.0b013e3283294d06.'}, {'pmid': '27555168', 'type': 'BACKGROUND', 'citation': 'Hattori K, Komasawa N, Miyazaki Y, Kido H, Deguchi S, Minami T. Muscle relaxant facilitates i-gel insertion by novice doctors: A prospective randomized controlled trial. J Clin Anesth. 2016 Sep;33:218-22. doi: 10.1016/j.jclinane.2016.03.058. Epub 2016 May 4.'}, {'pmid': '23122973', 'type': 'BACKGROUND', 'citation': 'Chen BZ, Tan L, Zhang L, Shang YC. Is muscle relaxant necessary in patients undergoing laparoscopic gynecological surgery with a ProSeal LMA? J Clin Anesth. 2013 Feb;25(1):32-5. doi: 10.1016/j.jclinane.2012.06.004. Epub 2012 Nov 2.'}, {'pmid': '30626406', 'type': 'DERIVED', 'citation': 'Byun SH, Kim SJ, Kim E. Comparison of the clinical performance of the flexible laryngeal mask airway in pediatric patients under general anesthesia with or without a muscle relaxant: study protocol for a randomized controlled trial. Trials. 2019 Jan 9;20(1):31. doi: 10.1186/s13063-018-3141-2.'}]}, 'descriptionModule': {'briefSummary': 'The use of laryngeal mask airway (LMA) is increasing in pediatric anesthesia because it provides lesser direct mechanical stimulation of the airway due to being placed above the larynx. However, LMA insertion can be more difficult in children than in adults due to their unique characteristics of pediatric airway. Neuromuscular blocking agents, so-called, muscle relaxants have long been used to facilitate insertion of airway devices. But there are pros and cons for the efficacy of muscle relaxants in LMA insertion, and most studies were investigated in adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged between 2 and 7 years of American Society of Anesthesiologists physical status (ASA PS) I or II who are planned to receive ophthalmic surgery under general anesthesia\n\nExclusion Criteria:\n\n* Refusal of consent\n* Present URI or other respiratory symptoms\n* Oro or facial anomaly\n* Poor dental condition\n* who cannot open their mouth or limited mouth opening\n* when the tracheal intubation is definitely needed'}, 'identificationModule': {'nctId': 'NCT03487003', 'acronym': 'LMA_MR', 'briefTitle': 'Muscle Relaxants on Efficacy of LMA Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Daegu Catholic University Medical Center'}, 'officialTitle': 'Comparison of the Clinical Performances of Flexible Laryngeal Mask Airway in Pediatric Patients Under General Anesthesia With or Without Muscle Relaxant: a Randomized Controlled Non-inferiority Trial', 'orgStudyIdInfo': {'id': 'DCMC#3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MR group', 'description': 'When the patients asleep, 0.3 mg/kg rocuronium is administered.', 'interventionNames': ['Drug: rocuronium']}, {'type': 'EXPERIMENTAL', 'label': 'NMR group', 'description': 'When the patients asleep, 0.3 mg/kg saline is administered.', 'interventionNames': ['Drug: saline']}], 'interventions': [{'name': 'rocuronium', 'type': 'DRUG', 'otherNames': ['Rocuronium bromide'], 'description': 'After standard anesthetic monitoring (non-invasive blood pressure monitor, pulse oximetry, 3-lead echocardiography), patients are inhaled with sevoflurane. When the patients asleep, 0.3 mg/kg rocuronium is administered. After 2 min, flexible laryngeal mask airway (fLMA) is inserted using standard method. The fLMA is inflated with air to 40 cmH2O using manometry. The oropharyngeal leak pressure (OLP) was determined by the method described by Lopez-Gil and colleagues.', 'armGroupLabels': ['MR group']}, {'name': 'saline', 'type': 'DRUG', 'otherNames': ['0.9% normal saline'], 'description': 'After standard anesthetic monitoring (non-invasive blood pressure monitor, pulse oximetry, 3-lead echocardiography), patients are inhaled with sevoflurane. When the patients asleep, 0.3 mg/kg saline is administered. After 2 min, flexible laryngeal mask airway (fLMA) is inserted using standard method. The fLMA is inflated with air to 40 cmH2O using manometry. The oropharyngeal leak pressure (OLP) was determined by the method described by Lopez-Gil and colleagues', 'armGroupLabels': ['NMR group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42472', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Daegu Catholic University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'overallOfficials': [{'name': 'Eugene Kim, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistant professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daegu Catholic University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Eugene Kim', 'investigatorAffiliation': 'Daegu Catholic University Medical Center'}}}}