Pupillary Dilation Reflex (PDR) Evaluation During General Anesthesia

Pupillary Dilation Reflex (PDR) Evaluation During General Anesthesia: a Pilot Study

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: Pupil dilation reflex measurement

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • University Hospital Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pupil dilation reflex measurement; Four measurements of PDR during surgery at standardized times	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pupillary Reflex Dilation	Pupillary Reflex Dilation is measured four times intraoperatively as a possible indicator of success of analgesia	Perioperative phase

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Investigators: Study Director: Robert Slappendel, MD, PhD, University Hospital, Antwerp; Principal Investigator: Michiel Baeten, MD, University Hospital, Antwerp

Publications and helpful links

Helpful Links

• Publication

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (ACTUAL): April 1, 2017
• Study Completion (ACTUAL): May 1, 2017

Study Registration Dates

• First Submitted: October 20, 2016
• First Submitted That Met QC Criteria: October 21, 2016
• First Posted (ESTIMATE): October 24, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 16, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Monitoring, Intraoperative; Heart Rate; Reflex, Pupillary
• Additional Relevant MeSH Terms: Eye Diseases; Pupil Disorders; Mydriasis
• Other Study ID Numbers: 16/40/410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO