Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-31 @ 8:24 AM
Study NCT ID:
NCT02467595
Status:
UNKNOWN
Last Update Posted:
2016-01-27
First Post:
2015-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on Anesthesia in Adenotonsillectomy
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': 'D005283', 'term': 'Fentanyl'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], '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': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-26', 'studyFirstSubmitDate': '2015-05-11', 'studyFirstSubmitQcDate': '2015-06-09', 'lastUpdatePostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Additive rocuronium', 'timeFrame': 'intraoperatve', 'description': 'We added rocuronium 0.3 mg kg-1 when there was more than one poor intubating condition.'}], 'primaryOutcomes': [{'measure': 'Conditions during tracheal intubation', 'timeFrame': 'At the time to tracheal intubation, after mask ventilation for 2 minutes', 'description': 'We assessed conditions during tracheal intubation as excellent, good or poor, and additionally using five variables; jaw relaxation, vocal cord position, vocal cord movement, coughing, and movement of the limbs.'}], 'secondaryOutcomes': [{'measure': 'time to extubation', 'timeFrame': 'intraoperatve', 'description': 'When surgery is end, we discontinue sevoflurane for maintaining anesthesia. So we check the time of this point until extubation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['no muscle relaxant', 'rocuronium', 'intubation condition', 'tracheal intubation', 'operating room time', 'low-dose rocuronium'], 'conditions': ['Muscle Relaxants']}, 'referencesModule': {'references': [{'pmid': '28964314', 'type': 'DERIVED', 'citation': 'Huh H, Park JJ, Kim JY, Kim TH, Yoon SZ, Shin HW, Lee HW, Lim HJ, Cho JE. Optimal dose of rocuronium bromide undergoing adenotonsillectomy under 5% sevoflurane with fentanyl. Int J Pediatr Otorhinolaryngol. 2017 Oct;101:70-74. doi: 10.1016/j.ijporl.2017.07.030. Epub 2017 Jul 25.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to compare the effect of no muscle relaxants and reduced-dose rocuronium on the anesthetic induction and emergence with fentanyl in children undergoing adenotonsillectomy.', 'detailedDescription': 'Adenotonsillectomy in children is a short surgical procedure under general anesthesia. The ideal muscle relaxant requires intense neuromuscular block for optimal surgical work and complete recovery of neuromuscular function immediately after the end of the surgical procedure without postoperative morbidity. Rocuronium is an intermediate acting neuromuscular blockade. Reduced-dose rocuronium has been reported to provide optimal anesthetic induction without delayed recovery. The investigators aimed to compare the effect of no muscle relaxants and reduced-dose rocuronium on the anesthetic induction and emergence with fentanyl in children undergoing adenotonsillectomy.\n\nAfter Institutional Review Board approval and written informed consent from the parents were obtained, 75 children (aged 3 to 10 years, ASA(The American Society of Anesthesia ) I or II) scheduled for adenotonsillectomy were included. Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and rocuronium 0.15 mg kg-1 (R 0.15 group) or rocuronium 0.3mg kg-1 (R 0.3 group) or saline (S group). After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. The investigators assessed conditions during tracheal intubation as excellent, good or poor, using five variables; jaw relaxation, vocal cord position, vocal cord movement, coughing, and movement of the limbs. The investigators added rocuronium 0.3 mg kg-1 when there was more than one poor condition. The investigators recorded the time from discontinuation of sevoflurane to time to extubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologist\\[ASA\\] class 1-2\n* scheduled adenotonsillectomy\n* written informed consent\n\nExclusion Criteria:\n\n* allergy of opioids, neuromuscular blocking drugs or other medications used during general anesthesia\n* known or suspected upper respiratory infection\n* disorder affecting neuromuscular blockade\n* suspected difficult tracheal intubation\n* Developmental Disability\n* known or suspected psychologic disorder\n* medication (psychoactive drugs)'}, 'identificationModule': {'nctId': 'NCT02467595', 'briefTitle': 'The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on Anesthesia in Adenotonsillectomy', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Anam Hospital'}, 'officialTitle': 'The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on the Anesthetic Condition With Fentanyl in Children Undergoing Adenotonsillectomy', 'orgStudyIdInfo': {'id': 'ED14142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'R 0.15 group', 'description': 'Rocuronium bromide 0.15 mg kg-1 group\n\n1. Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and rocuronium bromide 0.15 mg kg-1\n2. After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.\n3. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room.\n4. When poor intubating condition., added rocuronium bromide 0.3 mg kg-1 .\n\nDrug: Rocuronium bromide Rocuronium bromide 0.15 mg kg-1 was injected at I.V. line to patients (R 0.15 group), as muscle relaxants during anesthesia for adenotonsillectomy.', 'interventionNames': ['Drug: Rocuronium bromide 0.15 mg kg-1', 'Drug: Fentanyl', 'Drug: Propofol', 'Drug: Sevoflurane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'R 0.3 group', 'description': 'Rocuronium bromide 0.3 mg kg-1 group\n\n1. Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and rocuronium bromide 0.3 mg kg-1\n2. After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.\n3. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room.\n4. When poor intubating condition., added rocuronium bromide 0.3 mg kg-1 .\n\nDrug: Rocuronium bromide Rocuronium bromide 0.3 mg kg-1 was injected at I.V. line to patients (R 0.3 group), as muscle relaxants during anesthesia for adenotonsillectomy.', 'interventionNames': ['Drug: Rocuronium bromide 0.3 mg kg-1', 'Drug: Fentanyl', 'Drug: Propofol', 'Drug: Sevoflurane']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'S group', 'description': 'saline\n\n1. Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and saline.\n2. After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.\n3. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room.\n4. When poor intubating condition., added rocuronium bromide0.3 mg kg-1 .', 'interventionNames': ['Drug: Fentanyl', 'Drug: Propofol', 'Drug: Sevoflurane']}], 'interventions': [{'name': 'Rocuronium bromide 0.15 mg kg-1', 'type': 'DRUG', 'otherNames': ['Esmerone'], 'description': 'Rocuronium bromide 0.15 mg kg-1 was injected at I.V. line to patients (R 0.15 group), as muscle relaxants during anesthesia for adenotonsillectomy.', 'armGroupLabels': ['R 0.15 group']}, {'name': 'Rocuronium bromide 0.3 mg kg-1', 'type': 'DRUG', 'otherNames': ['Esmerone'], 'description': 'Rocuronium 0.3 mg kg-1 was injected at I.V. line to patients (R 0.3 group), as muscle relaxants during anesthesia for adenotonsillectomy.', 'armGroupLabels': ['R 0.3 group']}, {'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['하나구연산펜타닐주사'], 'description': 'Fentanyl 2 mcg kg-1 was injected at I.V. line to patients', 'armGroupLabels': ['R 0.15 group', 'R 0.3 group', 'S group']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Fresofol MCT 1%'], 'description': 'Propofol 2.5 mg kg-1 was injected at I.V. line to patients', 'armGroupLabels': ['R 0.15 group', 'R 0.3 group', 'S group']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['세보프란 흡입액'], 'description': 'After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.', 'armGroupLabels': ['R 0.15 group', 'R 0.3 group', 'S group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jang Eun Cho, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthesia and pain medicine department, Korea University Anam Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Sangjae Park', 'investigatorAffiliation': 'Korea University Anam Hospital'}}}}