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Clinical Trials/NCT02942316
NCT02942316
Completed
Not Applicable

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

University Hospital, Antwerp1 site in 1 country41 target enrollmentOctober 2016
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
University Hospital, Antwerp
Enrollment
41
Locations
1
Primary Endpoint
Pupillary Reflex Dilation
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
May 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Davina Wildemeersch

MD

University Hospital, Antwerp

Eligibility Criteria

Inclusion Criteria

  • Scheduled abdominal surgery

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

Outcomes

Primary Outcomes

Pupillary Reflex Dilation

Time Frame: Perioperative phase

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

Secondary Outcomes

  • Patient Movement(Perioperative phase)
  • Vital signs(Perioperative phase)

Study Sites (1)

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