Trials / Completed
CompletedNCT02916004
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- University Hospital, Antwerp · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2016-09-26
- Primary completion
- 2017-11-30
- Completion
- 2018-07-14
- First posted
- 2016-09-27
- Last updated
- 2023-05-15
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT02916004. Inclusion in this directory is not an endorsement.