Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-03-04 @ 10:12 PM
Study NCT ID:
NCT02358057
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2015-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can we Get Conscious Sedation by Combining Dexmedetomidine With Alfentanil?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D015760', 'term': 'Alfentanil'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-05', 'studyFirstSubmitDate': '2015-01-28', 'studyFirstSubmitQcDate': '2015-02-03', 'lastUpdatePostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ramsay score scale', 'timeFrame': '2 hours'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': '2 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Deep sedation', 'Dexmedetomidine', 'Emergency Service, Hospital'], 'conditions': ['Procedural Sedation']}, 'descriptionModule': {'briefSummary': 'The main objective is to determine if dexmedetomidine combine with alfentanil allow a level of conscious sedation within maximum security conditions in an emergency department.\n\nPatients included in the study will receive an injection of dexmedetomidine via a TIVA Injectomat Agilia, specially programmed for the injection of dexmedetomidine.\n\nPatients will also receive a dose of alfentanil, 1 minute before the technical act.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult over 18 years, of both sexes, for which a procedural sedation is needed in emergency room. The rules for sedation, in accordance with the international guidelines, are:\n\n* The insertion of a chest drain\n* Abscess incision and drainage\n* Closed reduction of a dislocated joint\n\nExclusion Criteria:\n\n* Patients refusing to participate in the study (refusal to sign the consent form)\n* Patients refusing sedation\n* Patients unable to participate in the study (consent is impossible to obtain)\n* Pregnant women\n* The hypersensitivity to the active ingredient, dexmedetomidine hydrochloride.\n* Patients with poor respiratory status determined by:\n\nRespiratory rate \\> 30 / min Oxygen saturation \\<90%\n\n* Patients with unfavorable hemodynamic status determined by :\n\nA heart rate \\> 120 / min A heart rate \\< 50 / min Systolic blood pressure ≥ 180 mmHg or ≤100mmHg Diastolic blood pressure ≥ 110mmHg\n\n* Patients with contraindication to the use of dexmedetomidine :\n\nAdvanced heart block (level 2 or 3) unless pacemaker Acute cerebrovascular disease'}, 'identificationModule': {'nctId': 'NCT02358057', 'briefTitle': 'Can we Get Conscious Sedation by Combining Dexmedetomidine With Alfentanil?', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Can we Get Conscious Sedation in Optimal Safety Conditions in an Emergency Department, by Combining Dexmedetomidine With Alfentanil?', 'orgStudyIdInfo': {'id': 'UCL - DexAlf - 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine and Alfentanil', 'description': 'Patients included in the study will receive an injection of dexmedetomidine via a TIVA Injectomat Agilia, specially programmed for the injection of dexmedetomidine.\n\nAt time zero, the patient will receive a bolus 1 mcg/ kg of dexmedetomidine during 10 minutes.\n\nPatients over 65 years will receive a bolus of 0.5 mcg/kg of dexmedetomidine during 10 minutes.\n\nAfterwards, the patient will receive a continuous injection of 0.6 mcg/kg/h of dexmedetomidine\n\nPatients will also receive a dose of alfentanil 1 mcg /kg, 1 minute before the technical act.\n\nA new alfentanil dose of 0.5 mcg / kg may be injected if pain reported by the patient corresponds to an EN \\> 50.\n\nThe maximum dose of alfentanil the patient can receive is 5 mcg / kg.', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: Alfentanil']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Dexdor', 'Precedex'], 'armGroupLabels': ['Dexmedetomidine and Alfentanil']}, {'name': 'Alfentanil', 'type': 'DRUG', 'otherNames': ['Rapifen'], 'armGroupLabels': ['Dexmedetomidine and Alfentanil']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Franck Verschuren, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Luc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}