Pupillometry in Identifying Risk of Postoperative Opioid-induced Respiratory Depression in Children Undergoing Tonsillectomy

NCT07573150 | Not Yet Recruiting FDA Device

• 2 other identifiers: NIH-OiRDR44DA055407
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Opioid-Induced Respiratory Depression; Postoperative Complications (Cardiopulmonary); Respiratory Complications Due to Anesthesia

Keywords

Sedation; Postoperative Period; Perioperative Monitoring; Pediatrics; Pupillary Light Reflex; Pupillometry; Analgesia; Anesthesia; Opioids; Hypoventilation; Oxygen Desaturation; Opioid-Induced Respiratory Depression; Respiratory Depression

Outcome Measures

Primary Outcomes (1)

• Occurrence of Postoperative Opioid-Induced Respiratory Depression

  Postoperative opioid-induced respiratory depression is defined as the occurrence of either (1) oxygen saturation (SpO2) \<90% for a sustained period, or (2) respiratory rate \<8 breaths per minute, in the absence of airway obstruction, during the post-anesthesia care unit stay. Events will be identified from clinical monitoring data and medical record documentation.

  From arrival in post-anesthesia care unit (PACU) through PACU discharge (up to 4 hours postoperatively)

Secondary Outcomes (4)

• Opioid Consumption

  From induction of anesthesia through transfer to the post-anesthesia care unit (PACU) (up to 2 hours) through PACU discharge (up to 4 hours postoperatively); data collection across these periods may extend up to 6 hours in total.

• Sedation Level

  During PACU stay (up to 4 hours postoperatively)

• Pain Scores

  During PACU stay (up to 4 hours postoperatively)

• Postoperative Nausea and Vomiting

  During PACU stay (up to 4 hours postoperatively)

Study Arms (1)

Pediatric Tonsillectomy Patients

Pediatric participants aged 3 to less than 18 years undergoing tonsillectomy. Participants will undergo non-invasive pupillometry measurements at predefined perioperative time points. Pupillometry data are collected for research purposes only and will not be used to guide clinical care. All participants will receive standard perioperative management as determined by the clinical team.

Device: Infrared Pupillometry

Interventions

Infrared Pupillometry DEVICE

Non-invasive pupillometry measurements will be performed using a commercially available, FDA-regulated infrared pupillometer. Measurements will be collected at predefined perioperative time points for research purposes only and will not be used to guide clinical care.

Also known as: Quantitative Pupillometry

Pediatric Tonsillectomy Patients

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of pediatric patients aged 3 to less than 18 years undergoing tonsillectomy with or without adenoidectomy at participating clinical sites. Participants will be enrolled from routine clinical care settings and will receive standard perioperative management. The study will include patients across a range of clinical characteristics representative of the typical pediatric tonsillectomy population.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NeurOptics Inc: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of Pittsburgh Medical Center: collaborator
• University of California, San Francisco: collaborator

Study Sites (2)

UCSF Benioff Children's Hospital

San Francisco, California, 94158, United States

Location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Postoperative Complications; Agnosia; Hypoventilation; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Study Officials

• Jeffrey W Oliver, PhD

  NeurOptics Inc

  STUDY DIRECTOR

Central Study Contacts

Alisha Maslanka, BS, CCRC

CONTACT

412-491-2748; alisha.maslanka@chp.edu

Senthilkumar Sadhasivam, MD

CONTACT

513-253-4684; sadhasivams@upmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 7, 2026
• Study Start: April 29, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-04

Locations

US (2)