Comparison of the Nociception Monitoring Devices During Cardiac Surgery.

Study Overview
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Brief Summary
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The purpose of this study is to compare the values of Surgical Pleth Index (SPI) and Nociception Level Index (NOL) measured simultaneously during cardiac surgery.

Detailed Description
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Participants are given oral and written information about the course of the trial, associated risks and benefits and about the handling of the personal data on the day before the surgery by one of the investigators. Participants are also given written information about patient's rights and insurance, the aim of the trial and its course. 40 adult cardiac surgery patients will be recruited for the study. NOL and SPI values will be measured during the cardiac surgery procedure. All patients receive oral premedication and standardized anesthesia.

Official Title
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Comparison of the Nociception Monitoring Devices During Cardiac Surgery.

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Device: PMD-200 monitor
* Device: Surgical Pleth Index monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: coronary artery disease of heart valve disorder qualified for the surgical treatment participant understands the course of the trial and its aim participant has given informed written consent Exclusion Criteria: participant has not given consent neurological or psychical disorders (psychiatric medication) dementia alcohol or substance abuse central nervous system medication (medication for epilepsy or neuropathic pain)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cardiac surgery patients<br>Patients scheduled for elective cardiac surgery (CABG or valve surgery). | Device: PMD-200 monitor<br>* Patient is connected to non-invasive PMD-200 monitor, measuring Nociception Level<br>Device: Surgical Pleth Index monitor<br>* Patient is connected to non-invasive monitor measuring Surgical Pleth Index<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPI values measured at several timepoints during cardiac surgery | SPI (Surgical Pleth Index) - index measuring nociceptive response based on pulse and pulse amplitude. | Values are measured during the course of the cardiac surgery procedure | 
| NOL values measured at several timepoints during cardiac surgery | NOL (Nociception Level Index) - nociception index based on heart rate and its changes, pulse wave amplitude, skin impedance and its changes, temperature and their variations | Values are measured during the course of the cardiac surgery procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, pain, nociception