Ignite Creation Date:
2025-12-24 @ 1:15 PM
Ignite Modification Date:
2025-12-30 @ 11:33 PM
Study NCT ID:
NCT04301895
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2020-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pupillary Unrest in Ambient Light, and Relationship to Opioid-Induced Respiratory Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D000083682', 'term': 'Opiate Overdose'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D062787', 'term': 'Drug Overdose'}, {'id': 'D063487', 'term': 'Prescription Drug Misuse'}, {'id': 'D000076064', 'term': 'Drug Misuse'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each subject is his/her own control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-05', 'studyFirstSubmitDate': '2020-03-03', 'studyFirstSubmitQcDate': '2020-03-05', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of environmental stimulation on decline in oxygen saturation to ≤ 90%.', 'timeFrame': '35 minutes', 'description': 'Conversational interaction and oxygen saturation measured by pulse oximeter.'}, {'measure': 'Impact of environmental stimulation on CO2 increase of 15% or more above baseline.', 'timeFrame': '35 minutes', 'description': 'Conversational interaction and CO2 measured by transcutaneous sensor.'}, {'measure': 'Correlation between estimated opioid concentration and deviation in pupillary measurement.', 'timeFrame': '35 minutes', 'description': 'Relationship of opioid concentration to pupillary unrest, measured by the pupillometer'}], 'secondaryOutcomes': [{'measure': 'Impact of environmental stimulation on opioid-related deviations in pupillary measurements.', 'timeFrame': '35 minutes', 'description': 'Impact of conversational interaction on degree of decline in pupillary unrest as measured by the pupillometer.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid; Intoxication, Perception Disturbance (Acute)', 'Acute Pain', 'Overdose of Opiate', 'Respiratory Depression', 'Safety Issues']}, 'referencesModule': {'references': [{'pmid': '33651243', 'type': 'DERIVED', 'citation': 'McKay RE, Kohn MA, Larson MD. Pupillary unrest, opioid intensity, and the impact of environmental stimulation on respiratory depression. J Clin Monit Comput. 2022 Apr;36(2):473-482. doi: 10.1007/s10877-021-00675-3. Epub 2021 Mar 2.'}]}, 'descriptionModule': {'briefSummary': 'Volunteers will receive a weight-based opioid (remifentanil) infusion for 10 minutes. In the first run, serial pupillary measurements (pupillary unrest, pupil diameter) will be taken at baseline, and at 2.5-minute intervals during the infusion and a 25-minute recovery period afterwards. After a washout period, the experiment will be repeated in each subject (second run). The two runs differ only by presence versus absence of verbal interaction.', 'detailedDescription': 'Healthy volunteers aged 20-55 will receive a weight-based opioid (remifentanil) infusion for 10 minutes. Vital signs including SpO2, transcutaneous CO2, and respiratory rate will be continuously measured.\n\nIn the first run, serial pupillary measurements (pupillary unrest, pupil diameter) will be taken at baseline, and at 2.5-minute intervals during the infusion and a 25-minute recovery period afterwards. After a washout period, the experiment will be repeated in each subject (second run). The two runs differ only by presence of ongoing verbal interaction versus complete avoidance of verbal interaction.\n\nIncidence of respiratory depression will be compared in the two protocols with or without verbal interaction. Correlation between pupil diameter and pupillary unrest with estimated opioid concentrations will be determined by regression. Difference between pupil measurement versus opioid concentration regressions will be compared by chi2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Active substance use disorder\n* Prior opioid use disorder\n* Opioid use within 30 days.'}, 'identificationModule': {'nctId': 'NCT04301895', 'briefTitle': 'Pupillary Unrest in Ambient Light, and Relationship to Opioid-Induced Respiratory Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Pupillary Unrest in Ambient Light, and Relationship to Opioid-Induced Respiratory Depression in Volunteers', 'orgStudyIdInfo': {'id': '221163'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Interactive', 'description': 'Subject will be asked to continually interactive with the investigators, answering a series of standard questions during the remifentanil infusion and recovery periods.', 'interventionNames': ['Behavioral: Continuous conversational interaction', 'Drug: Remifentanil infusion']}, {'type': 'OTHER', 'label': 'Non-interactive', 'description': 'All verbal interaction will be avoided and extraneous sounds will be eliminated from the environment during the remifentanil infusion and recovery periods.', 'interventionNames': ['Drug: Remifentanil infusion']}], 'interventions': [{'name': 'Continuous conversational interaction', 'type': 'BEHAVIORAL', 'otherNames': ['Environmental stimulation'], 'description': 'Maintaining continuous conversation, requiring that the subject answer questions and engage in discussion without interruption.', 'armGroupLabels': ['Interactive']}, {'name': 'Remifentanil infusion', 'type': 'DRUG', 'description': '10 minute remifentanil infusion', 'armGroupLabels': ['Interactive', 'Non-interactive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Rachel Eshima McKay, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Anesthesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}