Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT04483258
Status:
UNKNOWN
Last Update Posted:
2020-07-23
First Post:
2020-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Sevoflurane insufflation and intravenous sedation will be applied to the patients by changing them sequentially during each radiotherapy session.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-22', 'studyFirstSubmitDate': '2020-07-18', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of the successful radiotherapy sessions', 'timeFrame': 'during radiotherapy session', 'description': 'succesful: radiotherapy session without interruption unsuccesful: radiotherapy session with any interruption'}, {'measure': 'number of interruptions', 'timeFrame': 'during radiotherapy session', 'description': "number of interruptions related to inadequate sedation and patient's movement in radiotherapy session"}, {'measure': 'PSSS', 'timeFrame': 'during radiotherapy session', 'description': '5:Patient is moving 4: gentle immobilization for positioning. 3: do not require restraint to stop movement during the procedure. 2: Quiet (asleep or awake), not moving during procedure\n\n1: Deeply asleep with normal vital signs, but requiring airway intervention 0: Sedation associated with abnormal physiologic parameters that require acute intervention'}], 'secondaryOutcomes': [{'measure': 'sPO2', 'timeFrame': 'during radiotherapy session', 'description': 'peripheral oxygen saturation'}, {'measure': 'HR', 'timeFrame': 'during radiotherapy session', 'description': 'Heart Rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['insufflation sedation', 'intravenous sedation', 'radiotherapy anesthesia', 'pediatric sedation'], 'conditions': ['Pediatric Sedation', 'Radiotherapy', 'Inhalation Anesthesia']}, 'descriptionModule': {'briefSummary': 'aim of this cross-over study is to compare sedation with insufflated sevoflurane and intravenous sedation for pediatric radiotherapy patients', 'detailedDescription': 'aim of this cross-over study is to compare sedation with insufflated sevoflurane and intravenous sedation for pediatric radiotherapy(RT) patients in terms of success of the procedure (continuous completion of the RT session by providing inactivity) and complications such as desaturation, hypoventilation, airway spasm, bradycardia, tachycardia In addition, we aimed to investigate the incidence of anesthesia complications in RT patients and possible related factors with complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing radiotherapy session\n\nExclusion Criteria:\n\n* family refusal\n* chronic nausea and vomiting\n* apnea history, pneumonia, asthma, bronchiolitis etc. respiratory tract infection or diseases\n* cardiac disease\n* kidney failure\n* liver failure\n* anticipated difficult airway\n* metabolic diseases\n* neurological or muscular diseases.'}, 'identificationModule': {'nctId': 'NCT04483258', 'briefTitle': 'Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Cross-over Analysis of Sevoflurane Insufflation and Intravenous Sedation for Radiotherapy in Pediatric Patients', 'orgStudyIdInfo': {'id': 'E1-20-884'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sedation with Insufflation', 'description': 'Sedation induction via oxygen mask %8 sevoflurane and reducing %3 concentration after rediotherapy start', 'interventionNames': ['Procedure: Sedation with sevoflurane insufflation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'İntravenous sedation', 'description': 'Midazolam+ Ketamine sedation', 'interventionNames': ['Procedure: intravenous sedation']}], 'interventions': [{'name': 'Sedation with sevoflurane insufflation', 'type': 'PROCEDURE', 'description': 'Induction with %8sevoflurane after adequate sedation reducing %3', 'armGroupLabels': ['Sedation with Insufflation']}, {'name': 'intravenous sedation', 'type': 'PROCEDURE', 'description': 'midazolam +ketamine + atropine', 'armGroupLabels': ['İntravenous sedation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'İsmail Aytac', 'role': 'CONTACT', 'email': 'aytacismail1972@gmail.com', 'phone': '+905056340369'}], 'facility': 'Ankara City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'İsmail Aytac', 'role': 'CONTACT', 'email': 'aytacismail1972@gmail.com', 'phone': '05056340369'}], 'overallOfficials': [{'name': 'İsmail Aytac', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara City Hospital Anesthesiology Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'ismail aytaç', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}