Pain Assessment by Pupil Dilation Reflex (PDR) and Pupillary Pain Index (PPI) in Response to Noxious Stimulation in Anesthetized Adults

Not Applicable

Completed

• Conditions: Monitoring, Intraoperative; Nociceptive Pain
• Interventions: Procedure: PDR measurement

• Registration Number: NCT03140241
• Lead Sponsor: University Hospital, Antwerp

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.

Study Timeline

• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-04
• Study Start: 2017-05-07
• Primary Completion: 2017-06-29
• Study Completion: 2017-07-20
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-16
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PDR measurement	PDR measurement	Two measurements of PDR perioperatively before and after opioid administration

Primary Outcome Measures

Name	Time	Method
Stimulation Intensity	During perioperative period	Necessary stimulation intensity to dilate the pupil more than 13%

Secondary Outcome Measures

Name	Time	Method
Systolic blood pressure	During PDR measurements	Hypertension as a common used parameter for perioperative nociceptive assessment
Pupillary Pain Index score	During perioperative period	Device specific PPI score defined in accordance to stimulation intensity necessary for pupil dilation more than 13%
Heart rate	During PDR measurements	Tachycardia as a common used parameter for perioperative nociceptive assessment

Trial Locations

Locations (1)

University hospital Antwerp; 🇧🇪 Edegem, Antwerp, Belgium