Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-27 @ 10:44 PM
Study NCT ID:
NCT04598061
Status:
UNKNOWN
Last Update Posted:
2020-10-22
First Post:
2020-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2023-11-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-16', 'studyFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2020-10-16', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of motor block', 'timeFrame': 'immediately after procedure in the recovery room', 'description': 'Time at which the motor block is finished'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['less than 7 kg', 'undergoing an infra-umbilical surgery', 'Spinal anesthesia', 'Dexmedetomidine', 'respiratory complications'], 'conditions': ['Newborns', 'Infant', 'Spinal Anesthesia']}, 'descriptionModule': {'briefSummary': '* Spinal anesthesia in newborns is one of " Gold standard " techniques in short subumbilical surgeries (less than 30 minutes) with advantage of avoiding the risks inherent to general anesthesia.\n* Spinal anesthesia of the newborn remains a complex technical procedure with a failure rate of up to 16%. The child\'s movements and certain degrees of discomfort may also interfere with the successful completion of the procedure.\n* The second major issue of spinal anesthesia is the limitation of the motor block duration and the need for general anesthesia to complete the surgery\n* Spinal anesthesia duration can be prolonged by the addition of differents adjuvant such as opioid or alpha 2 adrenergic agonist.\n* Since 2018, dexmedetomidine, an alpha 2 adrenergic agonist with sedative, analgesic and anxiolytic properties, is being used as a current and standard practice in our anesthesia department. Intravenous administrationis performed ten to twenty minutes before spinal anesthesia placement in all children weighing less than 7 kg undergoing an infra-umbilical surgery of expected duration of less than 1 hour. This strategy ensures the child\'s comfort and allows the procedure to be performed under optimal conditions for practitionner.\n* The objective of this study is to review our practices and to evaluate the impact of the use of dexmedetomidine during spinal anesthesia of newborns and infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All children weighing less than 7 kg undergoing an infra-umbilical surgery of expected duration of less than 1 hour', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Newborns or Infants\n* less than 7 kg\n* Infra-umbilical surgery less than 1 hour\n* Spinal anesthesia\n\nExclusion criteria:\n\n* parental refusal\n* Contraindication to spinal anaesthesia (coagulation disorder, ongoing sepsis, spinal malformation...).\n* Contraindication to Dexmedetomidine (intracardiac conduction disorder, uncontrolled hemodynamic instability, alertness disorder)'}, 'identificationModule': {'nctId': 'NCT04598061', 'acronym': 'RACHI_dex', 'briefTitle': 'IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants : RACHI_dex', 'orgStudyIdInfo': {'id': 'RECHMPL20_0521'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery', 'description': 'Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery', 'interventionNames': ['Drug: Dexmedetomidine IV']}], 'interventions': [{'name': 'Dexmedetomidine IV', 'type': 'DRUG', 'description': 'Dexmedetomidine IV', 'armGroupLabels': ['Newborns or Infants less than 7 kg undergoing an infra-umbilical surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Montpellier', 'state': 'Hérault', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Chrystelle SOLA, PH', 'role': 'CONTACT', 'email': 'c-sola@chu-montpellier.fr', 'phone': '06 65 84 91 66'}], 'facility': 'University Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Chrystelle SOLA, PH', 'role': 'CONTACT', 'email': 'c-sola@chu-montpellier.fr', 'phone': '06 65 84 91 66'}], 'overallOfficials': [{'name': 'Chrystelle SOLA, PH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UH Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}