NOL Index in Response to Pacemaker Stimulation

NCT06696781 | Completed DMC

• 1 other identifier: 33964
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Nociceptive Pain

Keywords

cardiac surgery; nociception; NOL index; pacemaker

Outcome Measures

Primary Outcomes (1)

• NOL index

  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.

  Every minute during seven 5-minute intervals under various pacemaker settings, totaling 35 minutes of monitoring.

Study Arms (1)

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.

Procedure: Pacemaker stimulation

Interventions

Pacemaker stimulation 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.

Pacemaker

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Mechanically ventilated postoperative adult patients, admitted to the ICU within 6 hours after elective cardiac surgery.

You may qualify if:

• Informed consent
• Preoperative and postoperative sinus rhythm (50-90 bpm)
• Norepinephrine support \< 100 ng/kg/min

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

Bucharest, 022328, Romania

Location

Related Publications (1)

• Balan C, Barbulescu RT, Dumitrache A, Fodoroiu A, Morosanu B, Nica A, Stanculea I, Stoian I, Valeanu L, Wong A, Bubenek-Turconi SI. Nociception level index response to pacemaker stimulation. J Clin Monit Comput. 2025 Dec;39(6):1309-1316. doi: 10.1007/s10877-025-01377-w. Epub 2025 Nov 3.

  PMID: 41182599 DERIVED

MeSH Terms

Conditions

Nociceptive Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Serban-Ion Bubenek-Turconi, Professor

  CC Iliescu Cardiovascular Institute

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: November 20, 2024
• Study Start: November 18, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)