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

Pain Clinical Trial

— Pain@OR-kids  

Official title:

Evaluation of the Pupil Dilation Reflex (PDR) Using a Pupillary Pain Index (PPI) Stimulation Protocol in Response to Noxious Stimulation in Anaesthetized Children. A Proof of Concept Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03449732
• Other study ID #: 17/46/519
• Status: Completed
• Phase: N/A
• Start date: March 30, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively in infants, children and adolescents.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Monitoring, Intraoperative
• Mydriasis
• Pain

Intervention

Device:
• PDR measurement
PDR measurement at two standardized times perioperatively: Anesthetized subject by sevoflurane sedation until a minimum alveolar concentration (MAC) of at least 1,5 is reached Administration of fentanyl 2µg/kg, in the absence of adjustments in sedation depth

Locations

Country	Name	City	State
Belgium	University hospital Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stimulation Intensity	Necessary stimulation intensity to dilate the pupil more than 13%	During pupil measurements in the perioperative period
Secondary	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
Secondary	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	During PDR measurements
Secondary	Heart rate	Tachycardia as a common used parameter for perioperative nociceptive assessment	During PDR measurements