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Completed

NCT Number: NCT02942316

Pupillary Dilation Reflex (PDR) Evaluation During General Anesthesia

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Antwerp

Edegem, Antwerp, 2650, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pupil dilation reflex measurement

Device

Pupillometry (PDR) at four standardized times perioperatively

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

Primary outcomes

  1. 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

  1. Patient Movement

    Time frame: Perioperative phase

    Patient movement during surgery as a common used indicator for pain

  2. Vital signs

    Time frame: Perioperative phase

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

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 24, 2016
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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