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NOL Index in Response to Pacemaker Stimulation

NCT06696781 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-08-11

No results posted yet for this 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.

Conditions

  • Nociceptive Pain

Interventions

PROCEDURE

Pacemaker 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 & Collaborators

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

    lead OTHER

Principal Investigators

  • Serban-Ion Bubenek-Turconi, Professor · CC Iliescu Cardiovascular Institute

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-18
Primary Completion
2025-06-01
Completion
2025-07-01

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06696781 on ClinicalTrials.gov