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

Critical Illness Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02916004
• Other study ID #: 16/33/334
• Status: Completed
• Phase: N/A
• Start date: September 26, 2016
• Est. completion date: July 14, 2018

Study information

• Verified date: May 2023
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 14, 2018
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Mydriasis

Intervention

Device:
• Measurement 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

Locations

Country	Name	City	State
Belgium	University hospital Antwerp	Edegem	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test the feasibility of a objective pain evaluation tool; the nociception flexion reflex (NFR)		10 seconds after nociceptive stimulation
Primary	Test the feasibility of a objective pain evaluation tool; the pupillary dilatation reflex (PDR)		10 seconds after nociceptive stimulation
Secondary	Comparison NFR and the standard of care pain assessment (behavior pain scale)	Routine assessment of pain by attending nurse	In period of routine two hourly check up by nurse
Secondary	Comparison PDR and the standard of care pain assessment (behavior pain scale)	Routine assessment of pain by attending nurse	In period of routine two hourly check up by nurse