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Completed

NCT Number: NCT04712773

Comparison of the Nociception Monitoring Devices During Cardiac Surgery.

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.

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Key information

Conditions

Cardiac Surgery Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kuopio University Hospital

Kuopio, Northern Savonia, 70029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PMD-200 monitor

Device

Patient is connected to non-invasive PMD-200 monitor, measuring Nociception Level

Surgical Pleth Index monitor

Device

Patient is connected to non-invasive monitor measuring Surgical Pleth Index

Primary outcomes

  1. SPI values measured at several timepoints during cardiac surgery

    Time frame: 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.

  2. NOL values measured at several timepoints during cardiac surgery

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Acronym: SYDNOS

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2021
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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