Pupillary Dilation Reflex (PDR) Evaluation During General Anesthesia

May 16, 2018 updated by: Davina Wildemeersch, University Hospital, Antwerp

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/40/410

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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