NCT07573150 Pupillometry in Identifying Risk of Postoperative Opioid-induced Respiratory Depression in Children Undergoing Tonsillectomy
| NCT ID | NCT07573150 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NeurOptics Inc |
| Condition | Opioid-Induced Respiratory Depression |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-05-04 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2026-05-04 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate whether quantitative pupillometry measurements can be used to identify children at risk for postoperative opioid-induced respiratory depression (OIRD) following tonsillectomy. Opioid-induced respiratory depression is a serious and potentially life-threatening complication that can occur after surgery, and current monitoring approaches are limited in their ability to predict which patients are at highest risk. In this prospective observational cohort study, approximately 300 pediatric patients undergoing tonsillectomy will undergo non-invasive pupillometry measurements at defined perioperative time points, including preoperative, intraoperative, and postoperative periods. Pupillometry measurements will be collected using a commercially available, FDA-regulated infrared pupillometer. These measurements will include pupil size, constriction and dilation velocities, and latency in response to light stimulation. Pupillometry data will be collected for research purposes only and will not be used to guide clinical care or treatment decisions. Standard clinical care will not be altered as part of this study. Clinical outcomes, including the occurrence of postoperative opioid-induced respiratory depression, opioid use, sedation levels, pain scores, and other postoperative events, will be recorded from the medical record. The goal of this study is to evaluate the relationship between pupillary response patterns and the occurrence of postoperative respiratory depression, and to support the development of predictive models that may improve early identification of patients at risk for opioid-related adverse events.
Eligibility Criteria
Inclusion Criteria: * Age 3 to less than 18 years * Scheduled to undergo tonsillectomy with or without adenoidectomy * Planned postoperative recovery in a monitored clinical setting (e.g., post-anesthesia care unit) * Ability to obtain informed consent from parent or legal guardian and assent from the participant when developmentally appropriate Exclusion Criteria: * Known neurologic or ophthalmologic conditions that may affect pupillary function * Use of medications known to significantly alter pupillary response outside of standard perioperative care * Inability to obtain adequate pupillometry measurements (e.g., due to eye injury or inability to safely perform measurement) * Patients not receiving opioids as part of perioperative care * Any condition that, in the opinion of the investigator, would interfere with study participation or data interpretation
Contact & Investigator
Jeffrey W Oliver, PhD
STUDY DIRECTOR
NeurOptics Inc
Frequently Asked Questions
Who can join the NCT07573150 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 17 Years, studying Opioid-Induced Respiratory Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07573150 currently recruiting?
Yes, NCT07573150 is actively recruiting participants. Contact the research team at alisha.maslanka@chp.edu for enrollment information.
Where is the NCT07573150 trial being conducted?
This trial is being conducted at San Francisco, United States, Pittsburgh, United States.
Who is sponsoring the NCT07573150 clinical trial?
NCT07573150 is sponsored by NeurOptics Inc. The principal investigator is Jeffrey W Oliver, PhD at NeurOptics Inc. The trial plans to enroll 300 participants.
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