Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT03571867
Status:
UNKNOWN
Last Update Posted:
2018-06-28
First Post:
2018-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of The Severity of Agitation of Sugammadex and Atropine-Nesostigmine in Adenotonsillectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2018-06-05', 'studyFirstSubmitQcDate': '2018-06-18', 'lastUpdatePostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'agitation level', 'timeFrame': '1 month', 'description': 'Pediatric Anesthesia Emergence Delirium (PAED), which provides a score from 0 to 20'}], 'secondaryOutcomes': [{'measure': 'pain levels', 'timeFrame': '1 month', 'description': 'The pain levels were assessed with visual analogue scale (VAS) scores which assessment scale ranging from 0 to 10 according to the face expression was used'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adenotonsillectomy', 'Severity of Agitation', 'Sugammadex'], 'conditions': ['The Severity of Agitation in Adenotonsillectomy in Pediatric Patients']}, 'referencesModule': {'references': [{'pmid': '25535538', 'type': 'BACKGROUND', 'citation': 'Mohkamkar M Bs, Farhoudi F Md, Alam-Sahebpour A Md, Mousavi SA Md, Khani S PhD, Shahmohammadi S BSc. Postanesthetic Emergence Agitation in Pediatric Patients under General Anesthesia. Iran J Pediatr. 2014 Apr;24(2):184-90.'}]}, 'descriptionModule': {'briefSummary': 'the use of sugammadex during the reversal of neuromuscular blocking after adenotonsillectomy surgery in pediatric patients would be advantageous in terms of patient comfort and reducing side effects. Thus, we aimed to evaluate the time to extubation, agitation and pain scores in pediatric patients who underwent adenotonsillectomy and awakened with neostigmine and sugammadex in our study.', 'detailedDescription': "A total of 70 patients in the American Society of Anesthesiologists (ASA) I-II risk group, aged 5-13 years, who will be undergoing adenotonsillectomy with recurrent / chronic tonsillitis or obstructive sleep apnea in the otorhinolaryngology clinic of our hospital were included. Investigator did not assign specific interventions to the study participants. Patients were selected to sugammadex + saline group (Group S) and neostigmin+atropine group (Group N) and 35 patients were seleceted for each group randomly. Patients receive interventions as part of routine medical care, and a researcher studies the effect of the intervention.\n\nTracheal extubation time (from discontinuing anesthetics until extubation), Duration of anesthesia (from the injection of anesthetic until discontinuation) duration of the operation (from the injection of anesthetic until until the patient's discharge from the operating room) were recorded for each patient.\n\nWe assessed the agitation level with the Pediatric Anesthesia Emergence Delirium (PAED), which provides a score from 0 to 20, at first 15 minutes (T0), 1st (T1), 4th (T4), 8th (T8) and 12th (T12) hours post-extubation"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inclusion Criteria:A total of 70 patients in the American Society of Anesthesiologists (ASA) I-II risk group, aged 5-13 years, who will be undergoing adenotonsillectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient who will be undergoing adenotonsillectomy with recurrent / chronic tonsillitis or obstructive sleep apnea in the otorhinolaryngology clinic\n* American Society of Anesthesiologists (ASA) I-II risk group,\n* aged 5-13 years,\n\nExclusion Criteria:\n\n* patients with history of allergy to any medication used during general anesthesia,\n* known or suspected neuromuscular disorders that impair neuromuscular blockade,\n* liver and kidney disease,\n* asthma,\n* bleeding diathesis.\n* Written and verbal consents were obtained from the legal guardians of the patients who are blınded of the groups to participate in the study.'}, 'identificationModule': {'nctId': 'NCT03571867', 'briefTitle': 'Comparison of The Severity of Agitation of Sugammadex and Atropine-Nesostigmine in Adenotonsillectomy', 'organization': {'class': 'OTHER', 'fullName': 'Sakarya University'}, 'officialTitle': 'Comparison of The Severity of Agitation of Sugammadex and Atropine-Nesostigmine in Adenotonsillectomy in Pediatric Patients? : a Double Blind Randomised Clinical Trial', 'orgStudyIdInfo': {'id': 'sugammadex'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group Sugammadex', 'description': 'After surgery, while the TOF count was 2/4, the residual muscle relaxation was antagonized with 2 mg/kg iv sugammadex + 0.01 ml/kg saline in Group S'}, {'label': 'group Neostigmine', 'description': 'After surgery, while the TOF count was 2/4, the residual muscle relaxation was antagonized with 0.02 mg/kg neostigmin+0.01 mg/kg atropine in Group N.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54100', 'city': 'Sakarya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Havva Sayhan, Assis Prof', 'role': 'CONTACT', 'email': 'hsayhan@gmail.com', 'phone': '+905056621021'}, {'name': 'müge yılmaz', 'role': 'CONTACT'}], 'facility': 'Sakarya University Research and Training Hospital', 'geoPoint': {'lat': 39.50333, 'lon': 32.07583}}], 'centralContacts': [{'name': 'Havva Sayhan, Assis Prof', 'role': 'CONTACT', 'email': 'hsayhan@gmail.com', 'phone': '+905056621021'}, {'name': 'müge yılmaz, MD', 'role': 'CONTACT', 'email': 'hsayhan@gmail.com', 'phone': '+905056621021'}], 'overallOfficials': [{'name': 'Havva Sayhan, Assis Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Sakarya University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sakarya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Havva Sayhan', 'investigatorAffiliation': 'Sakarya University'}}}}