Clinical trial NCT02916004: The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.
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 Pupillary Dilatation Reflex.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: Analgesia
Pain measurement
Nociception
Electromyography
Electrical stimulation
Pupillometry
Critical care
Sedation
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Test the feasibility of a objective pain evaluation tool; the nociception flexion reflex (NFR)
timeFrame: 10 seconds after nociceptive stimulation
measure: Test the feasibility of a objective pain evaluation tool; the pupillary dilatation reflex (PDR)
timeFrame: 10 seconds after nociceptive stimulation
Secondary outcomes:
measure: Comparison NFR and the standard of care pain assessment (behavior pain scale)
timeFrame: In period of routine two hourly check up by nurse
measure: Comparison PDR and the standard of care pain assessment (behavior pain scale)
timeFrame: In period of routine two hourly check up by nurse
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University hospital Antwerp
state: Antwerpen
Study officials:
affiliation: University Hospital, Antwerp
name: Davina Wildemeersch, MD
role: PRINCIPAL_INVESTIGATOR
References: