Pupillary Dilation Reflex (PDR) Evaluation During General Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pupil dilation reflex measurement

Four measurements of PDR during surgery at standardized times

Group Type EXPERIMENTAL

Pupil dilation reflex measurement

Intervention Type DEVICE

Pupillometry (PDR) at four standardized times perioperatively

* after induction, before opioid administration
* after opioid administration, steady state
* surgical incision
* end of procedure

Interventions

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Pupil dilation reflex measurement

Pupillometry (PDR) at four standardized times perioperatively

* after induction, before opioid administration
* after opioid administration, steady state
* surgical incision
* end of procedure

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No