Opioid-Induced Respiratory Depression, Postoperative Complications (Cardiopulmonary), Respiratory Complications Due to Anesthesia
Conditions
Keywords
Sedation, Postoperative Period, Perioperative Monitoring, Pediatrics, Pupillary Light Reflex, Pupillometry, Analgesia, Anesthesia, Opioids, Hypoventilation, Oxygen Desaturation, Opioid-Induced Respiratory Depression, Respiratory Depression
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.
Detailed description
This is a prospective, observational cohort study designed to evaluate the relationship between perioperative pupillary responses and postoperative opioid-induced respiratory depression (OIRD) in pediatric patients undergoing tonsillectomy. Approximately 300 participants aged 3 to less than 18 years will be enrolled across participating clinical sites. Pupillometry measurements will be obtained using a portable, automated infrared pupillometer at predefined perioperative time points, including preoperative baseline, intraoperative periods, and postoperative recovery. Measurements will include resting pupil diameter, pupillary light reflex parameters (including percent constriction, constriction velocity, dilation velocity, and latency), and pupillary unrest in ambient light. Pupillometry measurements will be collected solely for research purposes and will not be used to guide clinical management. All patients will receive standard perioperative care as determined by the clinical team. The primary outcome is the occurrence of postoperative opioid-induced respiratory depression, defined as persistent oxygen desaturation (SpO2 \<90%) or respiratory rate \<8 breaths per minute in the absence of airway obstruction in the post-anesthesia care unit. Secondary outcomes include opioid consumption, sedation scores, pain scores, and postoperative complications such as nausea and vomiting. Data will be analyzed to assess the association between pupillary response parameters and the occurrence of respiratory depression, and to support development of predictive models for identifying patients at increased risk of opioid-related adverse events.
Interventions
DEVICEInfrared Pupillometry
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.
Sponsors
NeurOptics Inc
National Institute on Drug Abuse (NIDA)
University of Pittsburgh Medical Center
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Postoperative Opioid-Induced Respiratory Depression | From arrival in post-anesthesia care unit (PACU) through PACU discharge (up to 4 hours postoperatively) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Total opioid dose administered during the intraoperative and immediate postoperative period, recorded from the medical record and normalized to body weight where appropriate. |
| Sedation Level | During PACU stay (up to 4 hours postoperatively) | Sedation level assessed using clinically documented sedation scales recorded during routine care in the post-anesthesia care unit (PACU), including scales such as the Richmond Agitation-Sedation Scale (RASS; range -5 to +4, where more negative values indicate deeper sedation) or equivalent institution-specific scales. Higher levels of sedation correspond to lower (more negative) scores. |
| Pain Scores | During PACU stay (up to 4 hours postoperatively) | Pain intensity scores measured using age-appropriate validated scales (e.g., Numeric Rating Scale or FLACC) as recorded during routine clinical care. The Numeric Rating Scale (0 to 10, where 0 indicates no pain and 10 indicates worst possible pain) and for the Face, Legs, Activity, Cry, Consolability (FLACC) scale (0 to 10, where higher scores indicate greater pain), as recorded during routine clinical care in the post-anesthesia care unit (PACU). Scale selection will be based on patient age and clinical appropriateness. |
| Postoperative Nausea and Vomiting | During PACU stay (up to 4 hours postoperatively) | Occurrence of nausea and/or vomiting documented in the medical record during the PACU stay. |
Countries
United States
Contacts
CONTACTAlisha Maslanka, BS, CCRC
CONTACTSenthilkumar Sadhasivam, MD
STUDY_DIRECTORJeffrey W Oliver, PhD
NeurOptics Inc
Outcome results
None listed