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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-30

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain Monitoring, Intraoperative

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PDR measurement group A

Two measurements of PDR perioperatively before and after opioid administration in toddlers (28 days until 23 months)

Group Type EXPERIMENTAL

PDR measurement

Intervention Type DEVICE

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

PDR measurement group B

Two measurements of PDR perioperatively before and after opioid administration in children (2 until 11 years)

Group Type EXPERIMENTAL

PDR measurement

Intervention Type DEVICE

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

PDR measurement group C

Two measurements of PDR perioperatively before and after opioid administration in adolescents (12 until 18 years)

Group Type EXPERIMENTAL

PDR measurement

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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PPI assessment

Eligibility Criteria

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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

Minimum Eligible Age

28 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No