Clinical Trial: Pupillary Dilation Reflex (PDR) Evaluation During General Anesthesia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: University Hospital, Antwerp

Current Primary Outcome: Pupillary Reflex Dilation [ Time Frame: Perioperative phase ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University Hospital, Antwerp

Dates:
Date Received: October 20, 2016
Date Started: October 2016
Date Completion:
Last Updated: May 5, 2017
Last Verified: May 2017