Trial Outcomes & Findings for Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age (NCT NCT05391555)

NCT ID: NCT05391555

Last Updated: 2025-05-02

Results Overview

PUAL measured by pupillometer. PUAL at zero-moderate opioid concentration (\<1.8 ng/mL) versus high-toxic opioid concentration (\>2.5 ng/mL) were dichotomous classifiers. Receiver Operating Characteristic curve constructed, with AUROC reported

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 10 participants
• Primary outcome timeframe: Baseline, and every 2.5 minutes during 10-minute infusion and 25-minute recovery
• Results posted on: 2025-05-02

Participant Flow

Participant milestones

Measure	Remifentanil Infusion and Recovery Participants underwent a 10-minute remifentanil infusion. Pupillary measures were taken a baseline and every 2.5 minutes during the 10-minute infusion and 25-minute recovery period. Remifentanil Hydrochloride: Infusion of 0.2 µg/k/m for 5 minutes, the 0.3 µg/k/m for 5 minutes. Pupillometry measurement: Pupillary measurements were taken at baseline and every 2.5 minutes during the 10-minute infusion and 25-minute recovery period.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Remifentanil Infusion and Recovery n=10 Participants Participants underwent a 10-minute remifentanil infusion. Pupillary measures were taken a baseline and every 2.5 minutes during the 10-minute infusion and 25-minute recovery period. Remifentanil Hydrochloride: Infusion of 0.2 µg/k/m for 5 minutes, the 0.3 µg/k/m for 5 minutes. Pupillometry measurement: Pupillary measurements were taken at baseline and every 2.5 minutes during the 10-minute infusion and 25-minute recovery period.
Age, Customized Age 40-60 years	10 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race/Ethnicity, Customized White European	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	3 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants
Race/Ethnicity, Customized Latinx	2 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, and every 2.5 minutes during 10-minute infusion and 25-minute recovery

PUAL measured by pupillometer. PUAL at zero-moderate opioid concentration (<1.8 ng/mL) versus high-toxic opioid concentration (>2.5 ng/mL) were dichotomous classifiers.

Receiver Operating Characteristic curve constructed, with AUROC reported

Outcome measures

Measure

Remifentanil Infusion and Recovery n=10 Participants Participants underwent a 10-minute remifentanil infusion. Pupillary measures were taken a baseline and every 2.5 minutes during the 10-minute infusion and 25-minute recovery period. Remifentanil Hydrochloride: Infusion of 0.2 µg/k/m for 5 minutes, the 0.3 µg/k/m for 5 minutes. Pupillometry measurement: Pupillary measurements were taken at baseline and every 2.5 minutes during the 10-minute infusion and 25-minute recovery period.

Area Under the Time Concentration Curve (AUROC )

0.9700 Probability Interval 0.934 to 1.0

Adverse Events

Remifentanil Infusion and Recovery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rachel Eshima McKay

University of California San Francisco

Phone: 415-476-9035

Email: rachel.eshima@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place