Condition: Opioid-Induced Respiratory Depression · Postoperative Complications (Cardiopulmonary) · Respiratory Complications Due to Anesthesia · Sponsor: NeurOptics Inc
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…
This description comes directly from the study's public registry record.
Alisha Maslanka, BS, CCRC · 412-491-2748 · alisha.maslanka@chp.edu
Senthilkumar Sadhasivam, MD · 513-253-4684 · sadhasivams@upmc.edu
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| UCSF Benioff Children's Hospital | San Francisco, California, United States | Not Yet Recruiting |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07573150