search
Back to results

Pupillary Dilation Reflex (PDR) Evaluation During General Anesthesia

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Pupil dilation reflex measurement
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pain focused on measuring Heart Rate, Reflex, Pupillary, Monitoring, Intraoperative

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University hospital Antwerp

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pupil dilation reflex measurement

Arm Description

Four measurements of PDR during surgery at standardized times

Outcomes

Primary Outcome Measures

Pupillary Reflex Dilation
Pupillary Reflex Dilation is measured four times intraoperatively as a possible indicator of success of analgesia

Secondary Outcome Measures

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

Full Information

First Posted
October 20, 2016
Last Updated
May 16, 2018
Sponsor
University Hospital, Antwerp
search

1. Study Identification

Unique Protocol Identification Number
NCT02942316
Brief Title
Pupillary Dilation Reflex (PDR) Evaluation During General Anesthesia
Official Title
Pupillary Dilation Reflex (PDR) Evaluation During General Anesthesia: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Heart Rate, Reflex, Pupillary, Monitoring, Intraoperative

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pupil dilation reflex measurement
Arm Type
Experimental
Arm Description
Four measurements of PDR during surgery at standardized times
Intervention Type
Device
Intervention Name(s)
Pupil dilation reflex measurement
Intervention Description
Pupillometry (PDR) at four standardized times perioperatively after induction, before opioid administration after opioid administration, steady state surgical incision end of procedure
Primary Outcome Measure Information:
Title
Pupillary Reflex Dilation
Description
Pupillary Reflex Dilation is measured four times intraoperatively as a possible indicator of success of analgesia
Time Frame
Perioperative phase
Secondary Outcome Measure Information:
Title
Patient Movement
Description
Patient movement during surgery as a common used indicator for pain
Time Frame
Perioperative phase
Title
Vital signs
Description
Increased vital signs (heart rate, blood pressure) during surgery as a common used indicator for pain
Time Frame
Perioperative phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Slappendel, MD, PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michiel Baeten, MD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Davina Wildemeersch, MD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5931178/
Description
Publication

Learn more about this trial

Pupillary Dilation Reflex (PDR) Evaluation During General Anesthesia

We'll reach out to this number within 24 hrs