Nociceptive PainNCT06696781
NOL Index in Response to Pacemaker Stimulation
An observational study of Nociceptive Pain, run by Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nociceptive Pain
- What is being tested?
- Pacemaker stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteRomania
- Study dates
- 18 Nov 2024to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mechanically ventilated postoperative adult patients, admitted to the ICU within 6 hours after elective cardiac surgery.
Who may be able to join
- Informed consent
- Preoperative and postoperative sinus rhythm (50-90 bpm)
- Norepinephrine support < 100 ng/kg/min
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Romania1 site
"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
Bucharest, 022328
About this study
Official title: NOL Index in Response to Pacemaker Stimulation in Open-heart Surgery
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.
Read the 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.
- Conditions
- Nociceptive Pain
- Being tested
- Pacemaker stimulation
- Keywords
- cardiac surgery, nociception, NOL index, pacemaker
- Medical subject headings
- Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker stimulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Pacemaker stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every minute during seven 5-minute intervals under various pacemaker settings, totaling 35 minutes of monitoring.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start18 Nov 2024
- Primary completion1 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nociceptive PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balan Ion Cosmin, Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
- Investigators
- Serban-Ion Bubenek-Turconi, Professor, Study chair, CC Iliescu Cardiovascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696781
- Sponsor's protocol ID
- 33964
- Status last verified
- Aug 2025
- First submitted
- 17 Nov 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41182599
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOL Index in Response to Pacemaker Stimulation in Open-heart Surgery
- ClinicalTrials.gov ID
- NCT06696781
- Acronym / sponsor ID
- 33964
- Conditions
- Nociceptive Pain
- Keywords
- cardiac surgery, nociception, NOL index, pacemaker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. IliescuUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pacemaker | – | Procedure: Pacemaker stimulationMechanically 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated postoperative adult patients, admitted to the ICU within 6 hours after elective cardiac surgery.
Key inclusion criteria (3 listed)
- Informed consent
- Preoperative and postoperative sinus rhythm (50-90 bpm)
- Norepinephrine support < 100 ng/kg/min
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacemaker stimulationWe 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. | Procedure or surgery | Pacemaker |
Primary outcome
NOL index
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Derived from this study: PubMed 41182599Balan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serban-Ion Bubenek-Turconi, Professor study chair
CC Iliescu Cardiovascular Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nociceptive Pain, run by Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NOL index (time frame: Every minute during seven 5-minute intervals under various pacemaker settings, totaling 35 minutes of monitoring.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06696781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.