Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-02-11 @ 8:57 AM
Study NCT ID:
NCT03103360
Status:
COMPLETED
Last Update Posted:
2021-03-15
First Post:
2017-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pupillary Pain Index and Reaction to Skin Incision
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-12', 'studyFirstSubmitDate': '2017-03-31', 'studyFirstSubmitQcDate': '2017-03-31', 'lastUpdatePostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relationship between pre-incision pupillary pain index and post-incision heart rate increase', 'timeFrame': '4 minutes: one minute before incision, 3 minutes after incision'}, {'measure': 'Relationship between pre-incision pupillary pain index and post-incision blood pressure increase', 'timeFrame': '4 minutes: one minute before incision, 3 minutes after incision'}, {'measure': 'Relationship between pre-incision pupillary pain index and post-incision bispectral index increase', 'timeFrame': '4 minutes: one minute before incision, 3 minutes after incision'}, {'measure': 'Relationship between pre-incision pupillary pain index and post-incision movement occurrence', 'timeFrame': '4 minutes: one minute before incision, 3 minutes after incision'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain', 'Anesthesia', 'Surgery']}, 'descriptionModule': {'briefSummary': 'During routine general anesthesia (not standardized, left to the discretion of the attending anesthesiologist), pupillary pain index was measured one minute before skin incision. Then, variations in heart rate, blood pressure and bispectral index during the three minutes following skin incision were recorded, as well as the occurrence of movements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children under general anesthesia for an elective or emergent surgery requiring a skin incision in a body area not covered by regional anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient requiring general anesthesia\n* surgical procedure involving a skin incision\n* no regional anesthesia\n* written informed consent\n\nExclusion Criteria:\n\n\\- neurologic or ophthalmic disease'}, 'identificationModule': {'nctId': 'NCT03103360', 'briefTitle': 'Pupillary Pain Index and Reaction to Skin Incision', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Armand Trousseau'}, 'officialTitle': 'Relationship Between the Pupillary Pain Index Measured One Minute Before Incision and the Motor, Hemodynamic and Electroencephalographic Reaction to Skin Incision in Patients Under General Anesthesia', 'orgStudyIdInfo': {'id': 'PPI incision'}}, 'armsInterventionsModule': {'interventions': [{'name': 'videopupillometer', 'type': 'DEVICE', 'description': 'Measure of pupillary diameter and pupillary pain index via an infrared camera Each measure lasts approximately 20 seconds'}, {'name': 'skin incision', 'type': 'PROCEDURE', 'description': 'performed under general anesthesia by the surgeon, at the beginning of an elective or emergency surgery.'}]}, '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, MD-PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Armand Trousseau'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pr Isabelle CONSTANT', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pr Isabelle CONSTANT', 'investigatorAffiliation': 'Hôpital Armand Trousseau'}}}}