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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- University Hospital, Antwerp
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Stimulation Intensity
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Davina Wildemeersch
Principle investigator
University Hospital, Antwerp
Eligibility Criteria
Inclusion Criteria
- •Scheduled abdominal, urological or otorhinolaryngology surgery under general anaesthesia
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
Outcomes
Primary Outcomes
Stimulation Intensity
Time Frame: During pupil measurements in the perioperative period
Necessary stimulation intensity to dilate the pupil more than 13%
Secondary Outcomes
- Heart rate(During PDR measurements)
- Blood pressure(During PDR measurements)
- Pupillary Pain Index score(During pupil measurements in the perioperative period)