Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2026-01-13 @ 8:59 AM
Study NCT ID:
NCT02576600
Status:
COMPLETED
Last Update Posted:
2015-10-19
First Post:
2015-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pupillometry Guided Remifentanil Administration and Total Opioid Consumption During Propofol - Remifentanil TCI
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': 'D015742', 'term': 'Propofol'}, {'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-16', 'studyFirstSubmitDate': '2015-10-13', 'studyFirstSubmitQcDate': '2015-10-13', 'lastUpdatePostDateStruct': {'date': '2015-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'peroperative remifentanil consumption in µg/kg/min', 'timeFrame': 'duration of surgery'}], 'secondaryOutcomes': [{'measure': 'post-operative morphine requirements in mg/kg', 'timeFrame': '24 hours', 'description': 'includes initial morphine titration and subsequent PCA use'}, {'measure': 'peroperative propofol consumption in mg/kg/h', 'timeFrame': 'duration of surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The aim of this prospective randomized study was to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in major gynecological surgery. All patients were anesthetized with TCI of propofol and remifentanil. In the intervention group, peroperative remifentanil target was guided by pupillometry. In the other group, remifentanil was administered according to standard practice.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II\n* Elective gynecological surgery\n* No ophtalmologic or neurologic disease\n* No chronic analgesic medication\n* Expected length of surgery 60 minutes minimum\n\nExclusion Criteria:\n\n* ophtalmologic or neurologic disease\n* chronic analgesic medication'}, 'identificationModule': {'nctId': 'NCT02576600', 'briefTitle': 'Pupillometry Guided Remifentanil Administration and Total Opioid Consumption During Propofol - Remifentanil TCI', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Armand Trousseau'}, 'officialTitle': 'Pupillometry Guided Versus Standard Practice Remifentanil Administration and Total Opioid Consumption', 'orgStudyIdInfo': {'id': 'Anesthesie Trousseau 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PUPILLO', 'description': 'Videopupillometer Algiscan peroperative remifentanil target concentration adapted every five minutes to pupillary diameter in patients under propofol and remifentanil TCI', 'interventionNames': ['Device: Videopupillometer Algiscan', 'Drug: Propofol', 'Drug: Remifentanil']}, {'type': 'SHAM_COMPARATOR', 'label': 'STANDARD', 'description': 'peroperative remifentanil target concentration as standard practice in patients under propofol and remifentanil TCI', 'interventionNames': ['Other: Standard practice', 'Drug: Propofol', 'Drug: Remifentanil']}], 'interventions': [{'name': 'Videopupillometer Algiscan', 'type': 'DEVICE', 'description': 'pupillary diameter measurement every five minutes per-operatively', 'armGroupLabels': ['PUPILLO']}, {'name': 'Standard practice', 'type': 'OTHER', 'description': 'remifentanil administration left to the discretion of the anesthesiologist in charge according to standard practice', 'armGroupLabels': ['STANDARD']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'TCI', 'armGroupLabels': ['PUPILLO', 'STANDARD']}, {'name': 'Remifentanil', 'type': 'DRUG', 'description': 'TCI', 'armGroupLabels': ['PUPILLO', 'STANDARD']}]}, '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': 'Hôpital Armand Trousseau'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pr Isabelle CONSTANT', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor Isabelle Constant', 'investigatorFullName': 'Pr Isabelle CONSTANT', 'investigatorAffiliation': 'Hôpital Armand Trousseau'}}}}