Pupillary Dilation Reflex (PDR) Evaluation During General Anesthesia

Not Applicable

Completed

• Conditions: Pain
• Interventions: Device: Pupil dilation reflex measurement

• Registration Number: NCT02942316
• Lead Sponsor: University Hospital, Antwerp

Brief Summary

In this study, the pupillary dilation reflex is measured as a nociceptive indicator during elective abdominal surgery under general anesthesia.

Detailed Description

An infrared camera of the video pupillometer measures the pupillary dilation reflex (PDR) in response of a nociceptive stimulus. This autonomic reflex, parasympathetic mediated in sedated patients, can be generated by various pain stimuli (built in standardized protocol, surgical incision, ...) The PDR is a robust reflex, even in patients under general anesthesia, and provides a potential evaluation of the autonomous circuit within the nociceptive evaluation based on pupil dilation upon A-delta and C fibers in both electrical or mechanic stimulation. This mono-centric project involving American Society of Anesthesiologists (ASA) classification I-II patients undergoing elective abdominal surgery under general anesthesia are recruited. Enrolled patients perioperative undergo PDR measurements at four different standardized times.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-20
• Study First Submitted QC: 2016-10-21
• Study First Posted: 2016-10-24
• Primary Completion: 2017-04
• Study Completion: 2017-05
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-16
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Scheduled abdominal surgery
• ASA I-II

Exclusion Criteria

• History of eye deformity, invasive ophthalmologic surgery, impaired pupil reflex in advance
• Kown 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pupil dilation reflex measurement	Pupil dilation reflex measurement	Four measurements of PDR during surgery at standardized times

Primary Outcome Measures

Name	Time	Method
Pupillary Reflex Dilation	Perioperative phase	Pupillary Reflex Dilation is measured four times intraoperatively as a possible indicator of success of analgesia

Secondary Outcome Measures

Name	Time	Method
Patient Movement	Perioperative phase	Patient movement during surgery as a common used indicator for pain
Vital signs	Perioperative phase	Increased vital signs (heart rate, blood pressure) during surgery as a common used indicator for pain

Trial Locations

Locations (1)

University hospital Antwerp; 🇧🇪 Edegem, Antwerp, Belgium