Monitoring, Intraoperative, Pain
Conditions
Brief summary
After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively in infants, children and adolescents.
Detailed description
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.
Interventions
DEVICEPDR 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
Sponsors
University Hospital, Antwerp
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
28 Days to 18 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled abdominal, urological or otorhinolaryngology surgery under general anaesthesia * ASA I-II
Exclusion criteria
* History of eye deformity, invasive ophthalmologic surgery * Known cranial nerve(s) deficit * Infection of the eye * Predicted difficult airway management (Paediatric Difficult Airway Guidelines - Difficult Airway Society) * Chronic opioid use (\>3 months) * Ongoing treatment with beta-blockers, dopamine antagonists, topical atropine * Preoperatively administrated benzodiazepins or antiemetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stimulation Intensity | During pupil measurements in the perioperative period | Necessary stimulation intensity to dilate the pupil more than 13% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | During PDR measurements | 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 |
| Heart rate | During PDR measurements | Tachycardia as a common used parameter for perioperative nociceptive assessment |
| Pupillary Pain Index score | During pupil measurements in the perioperative period | Device specific PPI score defined in accordance to stimulation intensity necessary for pupil dilation more than 13% |
Countries
Belgium
Outcome results
None listed