Comparison of the Nociception Monitoring Devices During Cardiac Surgery.

Cardiac Surgery Clinical Trial

— SYDNOS  

Official title:

Comparison of the Nociception Monitoring Devices During Cardiac Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04712773
• Other study ID #: Kuopio University Hospital
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: January 1, 2025

Study information

• Verified date: October 2023
• Source: Kuopio University Hospital
• Contact: Pawel Florkiewicz, MD
• Phone: +358447175049
• Email: pawel.florkiewicz[@]kuh.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Device:
• PMD-200 monitor
Patient is connected to non-invasive PMD-200 monitor, measuring Nociception Level
• Surgical Pleth Index monitor
Patient is connected to non-invasive monitor measuring Surgical Pleth Index

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio	Northern Savo

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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