Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT01303627
Status:
COMPLETED
Last Update Posted:
2012-06-25
First Post:
2011-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety of Remifentanil Infusion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'derya_z@yahoo.com', 'phone': '0903125962553', 'title': 'Derya Özkan MD', 'organization': 'Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital 1. Anesthesiology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "The limitation of our study is age and ASA status of the included patients'. The relatively older or ASA status III,IV population may interfere the effect-site concentration TCI of remifentanil"}}, 'adverseEventsModule': {'timeFrame': 'During the surgery', 'description': 'serious and/or other \\[non-serious\\] adverse events were not collected/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Remifentanil Group', 'description': 'remifentanil group (group R) TCI effect-site of remifentanil at 1.5 ng/ml was continued until cLMA removal', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Remifentanil stopped at the end of the surgery', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Smooth cLMA Removal Condition (Score 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remifentanil Group', 'description': 'remifentanil group (group R) TCI effect-site of remifentanil at 1.5 ng/ml was continued until cLMA removal'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Remifentanil stopped at the and of the surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Statistical analyses were performed x2 test or Mann Whitney U test as approriate. A p value of \\<0.05 was considered statistically significant.', 'groupDescription': 'The incidence of complications on removal of the cLMA has been reported 54 % in awake patients group A power analysis indicated that a minimum 16 patients in each group were required to demonstrate a difference that 50% reduction the complications (a power of 80% and α error 0.05).', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At the end of the surgery', 'description': 'cLMA removal was accepted as successful (score 1) if none of the complications coughing, teeth clenching, gross purposeful movements, breath holding, laryngospasm, and desatura- tion to SpO2\\\\90% was observed. If any of these compli- cations was observed it was regarded as unsuccessful (score 2)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ultiva,Remifentanil,Opioid,Analgesic', 'description': 'Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery'}, {'id': 'FG001', 'title': 'Control', 'description': 'Control:Remifentanil stopped at the end of the surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'comment': 'One patient excluded from the study because of the failure while performing uretero-renoscopy', 'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'the failure while performing URS', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ultiva,Remifentanil,Opioid,Analgesic', 'description': 'Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery'}, {'id': 'BG001', 'title': 'Control', 'description': 'Control:Remifentanil stopped at the end of the surgery'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'spread': '13', 'groupId': 'BG000'}, {'value': '38', 'spread': '12', 'groupId': 'BG001'}, {'value': '39', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Turkey', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-15', 'studyFirstSubmitDate': '2011-02-24', 'resultsFirstSubmitDate': '2012-01-30', 'studyFirstSubmitQcDate': '2011-02-24', 'lastUpdatePostDateStruct': {'date': '2012-06-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-17', 'studyFirstPostDateStruct': {'date': '2011-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smooth cLMA Removal Condition (Score 1)', 'timeFrame': 'At the end of the surgery', 'description': 'cLMA removal was accepted as successful (score 1) if none of the complications coughing, teeth clenching, gross purposeful movements, breath holding, laryngospasm, and desatura- tion to SpO2\\\\90% was observed. If any of these compli- cations was observed it was regarded as unsuccessful (score 2)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Remifentanil', 'Laryngeal mask airway removal', 'Hemodynamic changing', 'Infusion', 'Ureterorenoscopy'], 'conditions': ['Urinary Tract Problem']}, 'referencesModule': {'references': [{'pmid': '19864308', 'type': 'RESULT', 'citation': 'Nho JS, Lee SY, Kang JM, Kim MC, Choi YK, Shin OY, Kim DS, Kwon MI. Effects of maintaining a remifentanil infusion on the recovery profiles during emergence from anaesthesia and tracheal extubation. Br J Anaesth. 2009 Dec;103(6):817-21. doi: 10.1093/bja/aep307. Epub 2009 Oct 28.'}]}, 'descriptionModule': {'briefSummary': 'The effect of maintenance remifentanil infusion with target controlled infusion during laryngeal mask airway removal on hemodynamic parameters and emergence quality is going to be investigated.', 'detailedDescription': 'In all patients (control group and remifentanil group induction of anesthesia will be achieved with desflurane and remifentanil.Anesthesia will be maintained with remifentanil (1-4 ng/mL) by TCI target controlled infusion, and desflurane . Throughout the surgery hemodynamic parameters are going to be recorded. As soon as the surgery has been finished, in control group remifentanil infusion and desflurane inhalation is going to be stopped.In remifentanil group,desflurane inhalation is going to be stopped and remifentanil infusion will be maintained until the removal of LMA. During the emergence period the time of eye opening, hemodynamic parameters and emergence quality (score 1-2)are going to be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II status\n* aged 18-60 years old\n* presenting for ureterorenoscopy\n\nExclusion Criteria:\n\n* history of hypertension\n* asthma and chronic obstructive lung disease\n* recent respiratory tract infections'}, 'identificationModule': {'nctId': 'NCT01303627', 'briefTitle': 'Safety of Remifentanil Infusion', 'organization': {'class': 'OTHER', 'fullName': 'Diskapi Teaching and Research Hospital'}, 'officialTitle': 'The Effects of Maintenance a Remifentanil Infusion on the Hemodynamic Variables and Recovery Quality', 'orgStudyIdInfo': {'id': 'DiskapiTRH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ultiva,remifentanil,opioid,analgesic', 'description': 'Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery', 'interventionNames': ['Drug: remifentanil']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'Control:Remifentanil stopped at the end of the surgery'}], 'interventions': [{'name': 'remifentanil', 'type': 'DRUG', 'description': '1-4 ng/mL i.v. infusion during the surgery, maintenance dosage till LMA removal is 1.5 ng/mL.', 'armGroupLabels': ['ultiva,remifentanil,opioid,analgesic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06110', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ministry of Health Diskapi Yildirim Beyazit Research and Training Hospital departement of 1. Anesthesiology', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Jülide Ergil, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ministry of Health Dıskapi Yildirim Beyazit Training and Research Hospital, Anesthesiology 1.'}, {'name': 'Alp Alptekin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital, Anesthesiology 1'}, {'name': 'Nihan Aktürk, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital , Anesthesiology 1'}, {'name': 'Haluk Gümüs, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital, Anesthesiology 1'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Teaching and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD consultant', 'investigatorFullName': 'derya özkan', 'investigatorAffiliation': 'Diskapi Teaching and Research Hospital'}}}}