Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-17 @ 8:35 PM
Study NCT ID:
NCT02648412
Status:
COMPLETED
Last Update Posted:
2016-12-22
First Post:
2016-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pupillary Dilation After Incremental Tetanic Stimulations Under Ketamine Sedation
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': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-21', 'studyFirstSubmitDate': '2016-01-04', 'studyFirstSubmitQcDate': '2016-01-05', 'lastUpdatePostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pupillary dilation: difference between post- and pre-stimulation pupillary diameter assessed by videopupillometry', 'timeFrame': '30 seconds after each stimulation (6 stimulations per patient)', 'description': 'Non-invasive measurement of pupillary diameter using an infrared camera, for each of the 6 stimulations per patient'}], 'secondaryOutcomes': [{'measure': 'Heart rate variation', 'timeFrame': '30 seconds after each stimulation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain', 'Anesthesia']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to describe the relationship between the intensity of a standardized tetanic stimulation and the associated reflex pupillary dilation in patients under ketamine sedation.\n\nAfter an intravenous bolus of 1 mg/kg of ketamine, tetanic stimulations were performed every minute at increasing intensities of 10, 20, 30, 40 and 60 milliamps (similar to the stimulations of neuromuscular blocking agents monitoring). Pupillary diameter was measured before and after each stimulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient admitted to pediatric burns care unit\n* Burnt skin area 5-40%\n* Scheduled for a dressing change under ketamine sedation\n\nExclusion Criteria:\n\n* Neurologic or ophthalmic disease'}, 'identificationModule': {'nctId': 'NCT02648412', 'briefTitle': 'Pupillary Dilation After Incremental Tetanic Stimulations Under Ketamine Sedation', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Armand Trousseau'}, 'officialTitle': 'Pupillary Diameter Variation After Standardized Tetanic Stimulations of Incremental Intensities in Patients Under Ketamine Sedation', 'orgStudyIdInfo': {'id': 'Pupillo ketamine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine sedation', 'description': 'Procedure scheduled under ketamine sedation. Baseline pupillary diameter measurement in alert subjects. Injection of a bolus of 1 mg/kg of ketamine. Every minute, tetanic stimulations of incremental intensities (10-20-30-40-60 milliamps), during 5 seconds.\n\nPupillary diameter measurement before and after each stimulation. End of study period, beginning of procedure.', 'interventionNames': ['Drug: ketamine', 'Procedure: Tetanic stimulations of incremental intensities']}], 'interventions': [{'name': 'ketamine', 'type': 'DRUG', 'description': 'bolus 1 mg/kg', 'armGroupLabels': ['Ketamine sedation']}, {'name': 'Tetanic stimulations of incremental intensities', 'type': 'PROCEDURE', 'description': "10-20-30-40-60 milliamps on the patient's left forearm", 'armGroupLabels': ['Ketamine sedation']}]}, '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'}}}}