Comparison of the Nociception Monitoring Devices During Cardiac Surgery.

Not Applicable

Completed

• Conditions: Cardiac Surgery
• Interventions: Device: PMD-200 monitor; Device: Surgical Pleth Index monitor

• Registration Number: NCT04712773
• Lead Sponsor: Kuopio University Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-12-21
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-15
• Study Start: 2021-02-22
• Status Verified: 2025-03
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiac surgery patients	Surgical Pleth Index monitor	Patients scheduled for elective cardiac surgery (CABG or valve surgery).
Cardiac surgery patients	PMD-200 monitor	Patients scheduled for elective cardiac surgery (CABG or valve surgery).

Primary Outcome Measures

Name	Time	Method
SPI values measured at several timepoints during cardiac surgery	Values are measured during the course of the cardiac surgery procedure	SPI (Surgical Pleth Index) - index measuring nociceptive response based on pulse and pulse amplitude.
NOL values measured at several timepoints during cardiac surgery	Values are measured during the course of the cardiac surgery procedure	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

Trial Locations

Locations (1)

Kuopio University Hospital; 🇫🇮 Kuopio, Northern Savo, Finland