Status:
COMPLETED
Evaluation of the Pupil Dilation Reflex in Response to Noxious Stimulation in Anaesthetized Children. A Proof of Concept Trial
Lead Sponsor:
University Hospital, Antwerp
Conditions:
Pain
Monitoring, Intraoperative
Eligibility:
All Genders
28-18 years
Phase:
NA
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 ane...
Eligibility Criteria
Inclusion
- Scheduled abdominal, urological or otorhinolaryngology surgery under general anaesthesia
- ASA I-II
Exclusion
- 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
Key Trial Info
Start Date :
March 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03449732
Start Date
March 30 2018
End Date
December 31 2021
Last Update
May 18 2022
Active Locations (1)
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1
University hospital Antwerp
Edegem, Antwerp, Belgium, 2650