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 Pupillary Dilatation Reflex.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Antwerp
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Test the feasibility of a objective pain evaluation tool; the nociception flexion reflex (NFR)
Study Overview
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 Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years of age or older
- •Critically ill with necessity to mechanic ventilation
- •Hospitalized at the ICU of our institution
- •Started sedation protocol (propofol/remifentanil or propofol/sufentanil)
- •Approved informed consent by family member or relative.
Exclusion Criteria
- •Known eye deformity or extented ophthalmologic surgery in history
- •Severe traumatic brain injury of fulminant stroke
- •Known (poly)neuropathy of complicated diabetes
- •Need for continuously curarization
- •Hemodynamic instability
Arms & Interventions
Measurement of NFR and PDR
Diagnostic intervention: excite NFR and PDR in comparison to behavior pain scale (BPS)
Intervention: Measurement of NFR and PDR (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Comparison PDR and the standard of care pain assessment (behavior pain scale)(In period of routine two hourly check up by nurse)
- Comparison NFR and the standard of care pain assessment (behavior pain scale)(In period of routine two hourly check up by nurse)
Investigators
Davina Wildemeersch
MD
University Hospital, Antwerp