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Clinical Trials/NCT04712773
NCT04712773
Completed
Not Applicable

Comparison of the Nociception Monitoring Devices During Cardiac Surgery.

Kuopio University Hospital1 site in 1 country40 target enrollmentFebruary 22, 2021
ConditionsCardiac Surgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Surgery
Sponsor
Kuopio University Hospital
Enrollment
40
Locations
1
Primary Endpoint
SPI values measured at several timepoints during cardiac surgery
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 22, 2021
End Date
March 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Kuopio University Hospital
Responsible Party
Sponsor

Eligibility Criteria

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)
  • alcohol or substance abuse
  • central nervous system medication (medication for epilepsy or neuropathic pain)

Outcomes

Primary Outcomes

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.

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

Study Sites (1)

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