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Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age

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ClinicalTrials.gov Identifier: NCT05391555
Recruitment Status : Not yet recruiting
First Posted : May 26, 2022
Last Update Posted : May 26, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This study will establish the relationship between magnitude of opioid exposure and a pupillary measure referred to as PUAL (pupillary unrest in ambient light), in subjects aged 40-60. Previous investigation demonstrated that loss of PUAL was a sensitive, discriminative indicator of opioid toxicity and respiratory depression among subjects aged 20-40 years old. Population data indicate that pupil size and PUAL decline slightly with age. The investigators will explore whether PUAL proves to be a sensitive indicator of opioid exposure and respiratory depression in this older group.

Condition or disease Intervention/treatment Phase
Opioid Toxicity Pupillary Miosis Respiratory Depression Drug: Remifentanil Hydrochloride Device: Pupillometry measurement Phase 2 Phase 3

Detailed Description:
Healthy volunteer subjects aged 40-60 will receive a standardized weight-based 10-minute remifentanil infusion protocol to achieve a peak estimated remifentanil effect site concentration of approximately 6 ng/mL. Pupillary measures will be taken at baseline and regular time intervals during and after the infusion, over a period of 35 minutes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Masking Description: The investigator determining the PUAL will be blinded to the opioid level concurrent with the measurement.
Primary Purpose: Diagnostic
Official Title: Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age
Estimated Study Start Date : May 30, 2022
Estimated Primary Completion Date : May 29, 2023
Estimated Study Completion Date : August 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Noninteractive, then Interactive
Participants undergo the infusion under noninteractive conditions, followed by a second drug infusion under interactive conditions.
Drug: Remifentanil Hydrochloride
Infusion of 0.2 µg/k/m for 5 minutes, the 0.3 µg/k/m for 5 minutes. Pupillary measurements will be taken at baseline and every 2.5 minutes during the 10-minute infusion and 25-minute recovery period.

Device: Pupillometry measurement
The pupil will be examined with the pupillometer at regular intervals, before during and after the opioid infusion

Experimental: Interactive, then Noninteractive
Participants undergo the infusion under interactive conditions, followed by a second drug infusion under noninteractive conditions.
Drug: Remifentanil Hydrochloride
Infusion of 0.2 µg/k/m for 5 minutes, the 0.3 µg/k/m for 5 minutes. Pupillary measurements will be taken at baseline and every 2.5 minutes during the 10-minute infusion and 25-minute recovery period.

Device: Pupillometry measurement
The pupil will be examined with the pupillometer at regular intervals, before during and after the opioid infusion




Primary Outcome Measures :
  1. Area Under the Time Concentration Curve (AUC 0-35 minutes) [ Time Frame: Baseline, and every 2.5 minutes during 10-minute infusion and 25-minute recovery ]
    PUAL measured by pupillometer.



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, BMI < 35 kg/m2

Exclusion Criteria:

  • current or recent opioid use
  • opioid or other substance use disorder
  • known or suspected OSA or sleep disordered breathing
  • ischemic heart disease, heart failure or symptomatic arrhythmia history
  • ocular disease or previous eye surgery
  • active use of alpha adrenergic blockers, anticholinergic medications,
  • active use of antidepressant or mood stabilizing medications
  • active use of phosphodiesterase inhibitors
  • use of stimulant or appetite suppressant medications
  • active use of antihypertensive or antiarrhythmic medications
  • use of topical eye medications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05391555


Contacts
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Contact: Rachel Eshima McKay, MD 415-502-1715 rachel.eshima@ucsf.edu

Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Rachel Eshima McKay, MD Professor of Anesthesia
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05391555    
Other Study ID Numbers: 21-34917
First Posted: May 26, 2022    Key Record Dates
Last Update Posted: May 26, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Miosis
Respiration Disorders
Respiratory Tract Diseases
Pupil Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents