Clinical Trial: Pain Assessment by Pupil Dilation Reflex (PDR) and Pupillary Pain Index (PPI) in Response to Noxious Stimulation in Anesthetized Adults

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Pain Assessment by Pupil Dilation Reflex (PDR) and Pupillary Pain Index (PPI) in Response to Noxious Stimulation in Anesthetized Adults

Brief Summary: After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively.

Detailed Summary: An infrared camera of the video pupillometer measures the pupillary dilation reflex (PDR) in response to incremental nociceptive stimuli. The PDR is a robust reflex, even in patients under general anesthesia, and may provide a potential evaluation of the autonomous nociceptive circuit. American Society of Anesthesiologists (ASA) classification I or II patients undergoing elective surgery under general anesthesia are recruited. Enrolled patients perioperative undergo PDR measurement at 2 different standardized times (before and after opioid administration) generated by an inbuilt pupillary pain index (PPI) protocol. PPI, as a surrogate for nociception includes noxious stimulations from 10 up to 60 milli ampere (mA) until pupil dilation is larger than 13% from baseline diameter. Therefore, no inappropriate high stimulation is executed.
Sponsor: University Hospital, Antwerp

Current Primary Outcome: Stimulation Intensity [ Time Frame: During perioperative period ]

Necessary stimulation intensity to dilate the pupil more than 13%


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pupillary Pain Index score [ Time Frame: During perioperative period ]
    Device specific PPI score defined in accordance to stimulation intensity necessary for pupil dilation more than 13%
  • Systolic blood pressure [ Time Frame: During PDR measurements ]
    Hypertension as a common used parameter for perioperative nociceptive assessment
  • Heart rate [ Time Frame: During PDR measurements ]
    Tachycardia as a common used parameter for perioperative nociceptive assessment


Original Secondary Outcome: Same as current

Information By: University Hospital, Antwerp

Dates:
Date Received: May 2, 2017
Date Started: April 20, 2017
Date Completion: September 2017
Last Updated: May 2, 2017
Last Verified: May 2017