Comparison of the Nociception Monitoring Devices During Cardiac Surgery.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04712773

Acronym

SYDNOS

Enrollment

Registered

2021-01-15

Start date

2021-02-22

Completion date

2025-03-01

Last updated

2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Keywords

cardiac surgery, pain, nociception

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.

Interventions

DEVICEPMD-200 monitor

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

DEVICESurgical Pleth Index monitor

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026