PJ-008200 Measurements on healthy subjects to design a nociception index

Completed

• Conditions: meten van pijn bij gezonde vrijwilligers; Nociception; Pain

• Registration Number: NL-OMON54413
• Lead Sponsor: Philips Patient Monitoring (Philips Medizin-Systeme Böblingen GmbH)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1) Age between 18 and 65 years old
2) ASA I Healthy subjects
3) BMI < 35
4) Females should be using contraception

Exclusion Criteria

1) Pregnancy (pregnancy test before start protocol, if female, with the
exception of post menstrual women)
2) Smoking
3) Alcohol abuse
4) Medication that influeunces the central or peripheral nervous system, or the
cardiovascular system
5) Drug use (drug test before start protocol)
6) Raynaud's disease (poor blood circulation)
7) Scleroderma, Dupuytren*s Contracture, or other Rheumatology issues
8) Depression and/or anxiety (the Hospital Anxiety and Depression Scale (HADS)
questionnaire is given before the start of the protocol. Subjects with a score
greater than or equal to 11 are excluded)
9) Food eaten in the 6 hours before the test
10) Fluid intake within less than 2 hours of the planned start of
experimentation
11) Use of caffeinated beverages in the 12 hours before the test
12) Use of caffeinated food (e.g. chocolate) in the 6 hours before the test

COVID-19 additional
13) Currently displaying COVID-19-related symptoms, namely a fever, cough
and/or difficulty breathing
14) Having been positively tested as infected with COVID-19 in the past 14 days
15) Travelled to or from high risk COVID-19 areas in the past 14 days
16) Been in contact with a (suspected) COVID-infected person in the past 14
days

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is the correlation between the presence of<br /><br>nociception and measures of nociception.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are:<br /><br>- the effect of remifentanil on the correlation between the index of<br /><br>nociception and the stimulus strengths and related subjective NRS scores.<br /><br>- the performance of within Philips Research earlier developed vital sign based<br /><br>(i.e. HRV, BP) algorithms.<br /><br>- the index of nociception with indices on the market such as ANI.<br /><br>- the performance of the PainChek facial expressions algorithm for pain<br /><br>detection</p><br>