Comparison of the Nociception Monitoring Devices During Cardiac Surgery. (SYDNOS)

Kuopio University Hospital

Status: Completed

Conditions: Cardiac Surgery

Treatments: Device: PMD-200 monitor; Device: Surgical Pleth Index monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT04712773

Kuopio University Hospital

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Cardiac surgery patients

Other group

Description:

Patients scheduled for elective cardiac surgery (CABG or valve surgery).

Treatment:

Device: Surgical Pleth Index monitor

Device: PMD-200 monitor