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NOL Index in Response to Pacemaker Stimulation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06696781
Enrollment
20
Registered
2024-11-20
Start date
2024-11-18
Completion date
2025-07-01
Last updated
2025-08-11

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

Conditions

Nociceptive Pain

Keywords

cardiac surgery, nociception, NOL index, pacemaker

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.

Interventions

PROCEDUREPacemaker stimulation

We deactivate the pacemaker to establish baseline measurements of NOL, bispectral index (BIS), mean arterial pressure (MAP), and heart rate (HR), recorded every minute for 5 minutes. We then adjust the pacemaker to 90 bpm and 110 bpm in subsequent 5-minute phases to assess the physiological responses. After deactivating the pacemaker to analyze washout effects, we reactivate it at 110 bpm to observe any changes. A temporary disconnection of the NOL monitor for 1 minute tests system reliability, followed by continued monitoring at the same rate for an additional 5 minutes. Each measurement phase averages data from the last 10 seconds each minute to ensure accuracy and reduce artifacts.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
NOL indexEvery 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.

Countries

Romania

Outcome results

None listed

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