NOL Index in Response to Pacemaker Stimulation

Completed

• Conditions: Nociceptive Pain

• Registration Number: NCT06696781
• Lead Sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

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.

Study Timeline

• Study First Submitted: 2024-11-17
• Study First Submitted QC: 2024-11-17
• Study Start: 2024-11-18
• Study First Posted: 2024-11-20
• Primary Completion: 2025-06-01
• Study Completion: 2025-07-01
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-07
• Last Update Posted: 2025-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NOL index	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.

Trial Locations

Locations (1)

"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases; 🇷🇴 Bucharest, Romania