NOL Index in Response to Pacemaker Stimulation

Last updated: August 7, 2025
Sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Overall Status: Completed

Phase

N/A

Condition

Acute Pain

Chronic Pain

Treatment

Pacemaker stimulation

Clinical Study ID

NCT06696781
33964
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed consent

  • Preoperative and postoperative sinus rhythm (50-90 bpm)

  • Norepinephrine support < 100 ng/kg/min

Exclusion

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

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Pacemaker stimulation
Phase:
Study Start date:
November 18, 2024
Estimated Completion Date:
July 01, 2025

Study 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.

Connect with a study center

  • "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

    Bucharest, 022328
    Romania

    Site Not Available

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