Monitoring, Intraoperative, Nociceptive Pain
Conditions
Brief summary
After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively.
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 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.
Interventions
PROCEDUREPDR measurement
PDR measurement at two standardized times perioperatively: 1. : anesthetized subject by propofol sedation until sedation depth monitor NeuroSense® (NeuroWave Systems Inc, Cleveland, OH) between 40-50 2. : administration of remifentanil via effect site target concentration (Minto-model) at 5 ng/ml, in the absence of adjustments in sedation depth
Sponsors
University Hospital, Antwerp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled abdominal or gynecological surgery * 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 (DAF Guidelines) * Chronic opioid use (\>3 months) * Ongoing treatment with beta-blockers, dopamine antagonists, topical atropine * Preoperatively administrated benzodiazepins or antiemetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stimulation Intensity | During perioperative period | Necessary stimulation intensity to dilate the pupil more than 13% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pupillary Pain Index score | During perioperative period | Device specific PPI score defined in accordance to stimulation intensity necessary for pupil dilation more than 13% |
| Systolic blood pressure | During PDR measurements | Hypertension as a common used parameter for perioperative nociceptive assessment |
| Heart rate | During PDR measurements | Tachycardia as a common used parameter for perioperative nociceptive assessment |
Countries
Belgium
Outcome results
None listed