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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02916004

Enrollment

Registered

2016-09-27

Start date

2016-09-26

Completion date

2018-07-14

Last updated

2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

Analgesia, Pain measurement, Nociception, Electromyography, Electrical stimulation, Pupillometry, Critical care, Sedation

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.

Interventions

DEVICEMeasurement of NFR and PDR

Feasibility testing of NFR and PDR in sedated, ventilated patients. Comparison of NFR and PDR with standard routine care of pain assessment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Test the feasibility of a objective pain evaluation tool; the nociception flexion reflex (NFR)	10 seconds after nociceptive stimulation
Test the feasibility of a objective pain evaluation tool; the pupillary dilatation reflex (PDR)	10 seconds after nociceptive stimulation

Secondary

Measure	Time frame	Description
Comparison NFR and the standard of care pain assessment (behavior pain scale)	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)	In period of routine two hourly check up by nurse	Routine assessment of pain by attending nurse

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026