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Clinical Trials/NCT06696781
NCT06696781
Completed
Not Applicable

NOL Index in Response to Pacemaker Stimulation in Open-heart Surgery

Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu1 site in 1 country20 target enrollmentNovember 18, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nociceptive Pain
Sponsor
Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Enrollment
20
Locations
1
Primary Endpoint
NOL index
Status
Completed
Last Updated
8 months ago

Overview

Brief Summary

The Nociception Level Index (NOL Index) utilizes various signals to assess the balance of nociception and antinociception during anesthesia. Its correlation with nociceptive stimuli and opioids is known, but its response to isolated heart rate changes remains uncertain. The aim is to investigate how cardiac pacing affects the NOL Index.

Detailed Description

The Nociception Level Index (NOL Index) represents an innovative approach to monitoring nociception during general anesthesia, utilizing a combination of signals from photoplethysmography, accelerometry, thermometry, and skin conductance to assess the balance between nociceptive and antinociceptive states. Research has already established how the NOL Index correlates with both nociceptive stimuli and opioid levels, providing valuable insights into patient responses. However, the impact of changes in heart rate, specifically through isolated cardiac pacing, on the NOL Index is not yet clear. The primary goal of this study is to explore and understand how cardiac pacing might influence the readings of the NOL Index, potentially offering a new dimension to managing anesthesia effectively.

Registry
clinicaltrials.gov
Start Date
November 18, 2024
End Date
July 1, 2025
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Responsible Party
Principal Investigator
Principal Investigator

Balan Ion Cosmin

Principal Investigator

Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

Eligibility Criteria

Inclusion Criteria

  • Informed consent
  • Preoperative and postoperative sinus rhythm (50-90 bpm)
  • Norepinephrine support \< 100 ng/kg/min

Exclusion Criteria

  • Redo or emergent surgery
  • History of any cardiac arrhythmia
  • Any cardiocirculatory support other than norepinephrine
  • Perioperative treatment with beta-blockers, calcium-channel blockers or ivabradine

Outcomes

Primary Outcomes

NOL index

Time Frame: Every minute during seven 5-minute intervals under various pacemaker settings, totaling 35 minutes of monitoring.

The Nociception Level Index (NOL Index) quantitatively evaluates the balance between nociception and antinociception in mechanically ventilated postoperative adult patients after elective cardiac surgery, utilizing a multiparametric approach that includes photoplethysmography, accelerometry, thermometry, and skin conductance.

Study Sites (1)

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