Evaluation of the Pupil Dilation Reflex in Response to Noxious Stimulation in Anaesthetized Children. A Proof of Concept Trial

University Hospital, Antwerp20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Pain Monitoring, Intraoperative

Interventions

PDR measurementDEVICE

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

Eligibility

Sex: ALLMin age: 28 DaysMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University hospital Antwerp

Edegem, Antwerp, Belgium

Outcomes

Primary Outcomes

Stimulation Intensity

Necessary stimulation intensity to dilate the pupil more than 13%

Time frame: During pupil measurements in the perioperative period

Secondary Outcomes

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

Data from ClinicalTrials.gov

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