An interventional study of PDR measurement in Pain and Monitoring, Intraoperative, sponsored by University Hospital, Antwerp. Completed at 1 site in Belgium. Open to participants aged 28 Days to 18 Years. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Diagnostic
After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively in infants, children and adolescents.
An infrared camera of the video pupillometer measures the pupillary dilation reflex (PDR) in response to incremental nociceptive stimuli. The PDR is a robust reflex, even in patients under general anesthesia, and may provide a potential evaluation of the autonomous nociceptive circuit. American Society of Anesthesiologists (ASA) classification I or II patients from the age of 28 days till 18 years undergoing elective surgery under general anesthesia are recruited. Enrolled patients perioperative undergo PDR measurement at 2 different standardized times (before and after opioid administration) generated by an inbuilt pupillary pain index (PPI) protocol. PPI, as a surrogate for nociception includes noxious stimulations from 10 up to 60 milli ampere (mA) until pupil dilation is larger than 13% from baseline diameter. Therefore, no inappropriate high stimulation is executed.
Exclusion Criteria:
Two measurements of PDR perioperatively before and after opioid administration in toddlers (28 days until 23 months)
Device: PDR measurement
Two measurements of PDR perioperatively before and after opioid administration in children (2 until 11 years)
Device: PDR measurement
Two measurements of PDR perioperatively before and after opioid administration in adolescents (12 until 18 years)
Device: PDR measurement
PDR measurement at two standardized times perioperatively: 1. Anesthetized subject by sevoflurane sedation until a minimum alveolar concentration (MAC) of at least 1,5 is reached 2. Administration of fentanyl 2µg/kg, in the absence of adjustments in sedation depth
Also known as: PPI assessment
Stimulation Intensity
Necessary stimulation intensity to dilate the pupil more than 13%
Time frame: During pupil measurements in the perioperative period
Pupillary Pain Index score
Device specific PPI score defined in accordance to stimulation intensity necessary for pupil dilation more than 13%
Time frame: During pupil measurements in the perioperative period
Blood pressure
Hypertension as a common used parameter for perioperative nociceptive assessment defined as an increase in systolic blood pressure by \>10% of the initial systolic blood pressure
Time frame: During PDR measurements
Heart rate
Tachycardia as a common used parameter for perioperative nociceptive assessment
Time frame: During PDR measurements
Plan to share: Undecided
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University Hospital, Antwerp