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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDR measurement group A | Experimental | Two measurements of PDR perioperatively before and after opioid administration in toddlers (28 days until 23 months) |
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| PDR measurement group B | Experimental | Two measurements of PDR perioperatively before and after opioid administration in children (2 until 11 years) |
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| PDR measurement group C | Experimental | Two measurements of PDR perioperatively before and after opioid administration in adolescents (12 until 18 years) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDR measurement | Device | PDR measurement at two standardized times perioperatively:
|
| Measure | Description | Time Frame |
|---|---|---|
| Stimulation Intensity | Necessary stimulation intensity to dilate the pupil more than 13% | During pupil measurements in the perioperative period |
| Measure | Description | Time Frame |
|---|---|---|
| Pupillary Pain Index score | Device specific PPI score defined in accordance to stimulation intensity necessary for pupil dilation more than 13% | During pupil measurements in the perioperative period |
| Blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathalie Kegels, MD | University Hospital, Antwerp | Principal Investigator |
| Vera Saldien, MD | University Hospital, Antwerp | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Antwerp | Edegem | Antwerp | 2650 | Belgium |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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
| During PDR measurements |
| Heart rate | Tachycardia as a common used parameter for perioperative nociceptive assessment | During PDR measurements |