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Completed

NCT Number: NCT02916004

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

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.)

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Key information

Conditions

Critical Illness Agnosia Disease Attributes Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Antwerp

Edegem, Antwerpen, 2650, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measurement of NFR and PDR

Device

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

Primary outcomes

  1. Test the feasibility of a objective pain evaluation tool; the nociception flexion reflex (NFR)

    Time frame: 10 seconds after nociceptive stimulation

  2. Test the feasibility of a objective pain evaluation tool; the pupillary dilatation reflex (PDR)

    Time frame: 10 seconds after nociceptive stimulation

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Sep 27, 2016
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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