Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-03-05 @ 6:40 PM
Study NCT ID:
NCT02646592
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2016-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Bolus of 10 µg/kg of Alfentanil on the Pupillary Pain Index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015760', 'term': 'Alfentanil'}, {'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2016-01-04', 'studyFirstSubmitQcDate': '2016-01-04', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change between Pupillary Pain Index before and after alfentanil bolus', 'timeFrame': 'Five minutes before incision and just before incision. Each measure = 20 seconds', 'description': 'pupillometry'}]}, 'conditionsModule': {'conditions': ['Pain', 'Anesthesia']}, 'referencesModule': {'references': [{'pmid': '30198934', 'type': 'DERIVED', 'citation': 'Sabourdin N, Diarra C, Wolk R, Piat V, Louvet N, Constant I. Pupillary Pain Index Changes After a Standardized Bolus of Alfentanil Under Sevoflurane Anesthesia: First Evaluation of a New Pupillometric Index to Assess the Level of Analgesia During General Anesthesia. Anesth Analg. 2019 Mar;128(3):467-474. doi: 10.1213/ANE.0000000000003681.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the Pupillary Pain Index before and after a bolus of alfentanil in children under general anesthesia, before skin incision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective surgery under general anesthesia\n* Written informed consent\n\nExclusion Criteria:\n\n* Chronic pain\n* Preoperative analgesic drug\n* Neurologic disease\n* Ophtalmic disease'}, 'identificationModule': {'nctId': 'NCT02646592', 'briefTitle': 'Effect of a Bolus of 10 µg/kg of Alfentanil on the Pupillary Pain Index', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Armand Trousseau'}, 'officialTitle': 'Effect of a Bolus of 10 µg/kg of Alfentanil on the Pupillary Pain Index', 'orgStudyIdInfo': {'id': 'PPI Alfentanil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'alfentanil', 'description': 'Children under general anesthesia for elective surgery. Induction with sevoflurane or propofol according to the preference of the patient.\n\nMaintenance with sevoflurane. 5 minutes before skin incision, first assessment of the pupillary pain index. Then injection of 10 µg/kg of alfentanil. After 5 minutes second assessment of pupillary pain index. End of study period, beginning of surgery.', 'interventionNames': ['Drug: Alfentanil', 'Drug: sevoflurane or propofol']}], 'interventions': [{'name': 'Alfentanil', 'type': 'DRUG', 'description': 'Bolus of alfentanil 10 µg/kg 5 minutes before skin incision', 'armGroupLabels': ['alfentanil']}, {'name': 'sevoflurane or propofol', 'type': 'DRUG', 'armGroupLabels': ['alfentanil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': "Departement d'anesthesie Hopital Armand Trousseau", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Isabelle Constant, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Armand Trousseau'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pr Isabelle CONSTANT', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pr Isabelle CONSTANT', 'investigatorAffiliation': 'Hôpital Armand Trousseau'}}}}