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

Not Applicable

Completed

• Conditions: Monitoring, Intraoperative; Pain
• Interventions: Device: PDR measurement

• Registration Number: NCT03449732
• Lead Sponsor: University Hospital, Antwerp

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.

Study Timeline

• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-02-27
• Study First Posted: 2018-02-28
• Study Start: 2018-03-30
• Primary Completion: 2021-04-26
• Study Completion: 2021-12-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PDR measurement group A	PDR measurement	Two measurements of PDR perioperatively before and after opioid administration in toddlers (28 days until 23 months)
PDR measurement group B	PDR measurement	Two measurements of PDR perioperatively before and after opioid administration in children (2 until 11 years)
PDR measurement group C	PDR measurement	Two measurements of PDR perioperatively before and after opioid administration in adolescents (12 until 18 years)

Primary Outcome Measures

Name	Time	Method
Stimulation Intensity	During pupil measurements in the perioperative period	Necessary stimulation intensity to dilate the pupil more than 13%

Secondary Outcome Measures

Name	Time	Method
Heart rate	During PDR measurements	Tachycardia as a common used parameter for perioperative nociceptive assessment
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
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%

Trial Locations

Locations (1)

University hospital Antwerp; 🇧🇪 Edegem, Antwerp, Belgium