Clinical Trial: The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.

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

Official Title: Responsiveness to Noxious Stimuli in Ventilated Intensive Care Unit (ICU) Patients With Propofol / Remifentanil Sedation Protocol by Using the Nociception Flexion Reflex (RIII Reflex) and the Pupillar

Brief Summary:

The aim of the study was to describe the feasibility of the nociception flexion reflex and the pupillary dilatation reflex as objective pain assessment tools in the Intensive Care Unit (ICU). Furthermore to describe the relationship between the responses and the standard of care pain evaluation in the critically ill sedated patients.

Patients were under propofol / remifentanil or propofol / sufentanil sedation protocol during measurements in a stair-case increasing intensity model of standardized stimulations. (Stimulation intensity are similar to the stimulations of neuromuscular blocking agents monitoring.)


Detailed Summary:

Pupillary dilatation reflex: tetanic stimulations at the nervus medianus were performed starting form 10 milliamperes (mA) up to 60mA. Pupillary diameter was measured before, during and after stimulation.

Nociception flexion reflex: tetanic stimulations at the nervus suralis were performed starting form 0.5mA in increasing steps via an automated RIII (NFR) threshold tracking model.


Sponsor: University Hospital, Antwerp

Current Primary Outcome:

  • Test the feasibility of a objective pain evaluation tool; the nociception flexion reflex (NFR) [ Time Frame: 10 seconds after nociceptive stimulation ]
  • Test the feasibility of a objective pain evaluation tool; the pupillary dilatation reflex (PDR) [ Time Frame: 10 seconds after nociceptive stimulation ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Comparison NFR and the standard of care pain assessment (behavior pain scale) [ Time Frame: In period of routine two hourly check up by nurse ]
    Routine assessment of pain by attending nurse
  • Comparison PDR and the standard of care pain assessment (behavior pain scale) [ Time Frame: In period of routine two hourly check up by nurse ]
    Routine assessment of pain by attending nurse


Original Secondary Outcome: Same as current

Information By: University Hospital, Antwerp

Dates:
Date Received: September 15, 2016
Date Started: October 2016
Date Completion: January 2018
Last Updated: October 14, 2016
Last Verified: October 2016