Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-28 @ 9:12 AM
Study NCT ID:
NCT01006668
Status:
UNKNOWN
Last Update Posted:
2014-08-29
First Post:
2009-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-08-28', 'studyFirstSubmitDate': '2009-10-19', 'studyFirstSubmitQcDate': '2009-11-02', 'lastUpdatePostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare recovery time between sevoflurane and propofol for intubation of neonates.', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'To compare efficacy and tolerance between sevoflurane and propofol for intubation of neonates.', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neonates', 'Intensive care', 'Endotracheal intubation', 'Neonates in intensive care'], 'conditions': ['Endotracheal Intubation']}, 'descriptionModule': {'briefSummary': 'Endotracheal intubation is a painful and stressful procedure, which is associated with acute increases of blood pressure, intracranial pressure, bradycardia and hypoxemia with high morbidity.\n\nThe aim of the study is to compare recovery time, efficacy and tolerance in a randomized controlled study, between sevoflurane and propofol for intubation in neonates in Neonatal Intensive Care Unit.', 'detailedDescription': 'Background:\n\nEndotracheal intubation is a painful and stressful procedure, which is associated with acute increases of blood pressure, intracranial pressure, bradycardia and hypoxemia with hight morbidity.\n\nIn 2001, in France more than 50% of intubations in neonates were performed without any premedication or anesthesia.\n\nThe most frequently used anesthesias are based on benzodiazepine or opioids. Unfortunately, these treatments are responsible for respiratory and hemodynamic adverse effects. Recently, 2 new possibilities for anesthesia before intubation has been tested: propofol was better than association of morphine, succinylcholine and atropine and we shaw that inhaled sevoflurane was better than no treatment.\n\nThe aim of the present study is to compare recovery time, efficacy and tolerance in a randomized controlled study, between sevoflurane and propofol for intubation in neonates in Neonatal Intensive Care Unit.\n\nObjectives:\n\nThe objective of this study is to compare recovery time, efficacy and tolerance in a randomized controlled study, between sevoflurane and propofol for intubation of neonates.\n\nMethods:\n\nProspective, controlled, randomized, monocentric study.\n\nSubjects:\n\nNeonates in neonatal intensive care requiring intubation.\n\nEvaluation criteria:\n\nRecovery time after intubation, facilitation of procedure, tolerance of treatment (mean arterial pressure, apnea).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neonates\n* Hospitalized in neonatal intensive care unit\n* Needing of an endotracheal intubation\n\nExclusion Criteria:\n\n* Emergency state\n* Predictable difficult endotracheal intubation\n* Decrease of blood pressure\n* Neurological disorders\n* Morphinic treatment'}, 'identificationModule': {'nctId': 'NCT01006668', 'briefTitle': 'Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care', 'orgStudyIdInfo': {'id': '2009-13'}, 'secondaryIdInfos': [{'id': '2009-013283-39'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sevoflurane', 'description': 'Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas.', 'interventionNames': ['Drug: Administration of sevoflurane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'description': 'Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary', 'interventionNames': ['Drug: Administration of propofol']}], 'interventions': [{'name': 'Administration of sevoflurane', 'type': 'DRUG', 'description': 'Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas.', 'armGroupLabels': ['Sevoflurane']}, {'name': 'Administration of propofol', 'type': 'DRUG', 'description': 'Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary.', 'armGroupLabels': ['Propofol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabrice MICHEL', 'role': 'CONTACT', 'email': 'fabrice.michel@ap-hm.fr'}, {'name': 'Fabrice MICHEL', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assistance Publique - Hôpitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Fabrice MICHEL', 'role': 'CONTACT', 'email': 'fabrice.michel@ap-hm.fr'}], 'overallOfficials': [{'name': 'Fabrice MICHEL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}