NOL Index in Response to Pacemaker Stimulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-18

Study Completion Date

2025-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nociceptive Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pacemaker

Mechanically ventilated postoperative adult patients, admitted to the intensive care unit (ICU) within 6 hours after elective cardiac surgery, undergo pacemaker stimulation at various rates to observe how this influences the NOL Index.

Pacemaker stimulation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No