Investigating how heart pacing affects pain response during anesthesia
NOL Index in Response to Pacemaker Stimulation in Open-heart Surgery
This study is testing how heart pacing during surgery affects pain responses in patients under anesthesia to see if it can improve pain management.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu Academic / other |
| Locations | 1 site (Bucharest) |
| Trial ID | NCT06696781 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the Nociception Level Index (NOL Index), which measures the balance between nociception and antinociception during anesthesia using various physiological signals. The research aims to determine how isolated cardiac pacing influences the NOL Index readings, which could enhance our understanding of pain management in patients undergoing cardiac surgery. By analyzing the relationship between heart rate changes and nociceptive responses, the study seeks to provide insights that could improve anesthesia practices. Participants will be monitored during their surgical procedures to gather data on the NOL Index in response to pacemaker stimulation.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing cardiac surgery with stable preoperative and postoperative sinus rhythm.
Not a fit: Patients with a history of cardiac arrhythmias or those requiring perioperative cardiocirculatory support other than norepinephrine may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies during anesthesia for cardiac surgery patients.
How similar studies have performed: While the NOL Index has been studied in relation to nociceptive stimuli and opioids, the specific impact of cardiac pacing on the NOL Index is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent * Preoperative and postoperative sinus rhythm (50-80 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
Where this trial is running
Bucharest
- "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases — Bucharest, Romania (Recruiting)
Study contacts
- Study coordinator: Cosmin Balan, PhD
- Email: cosmin13mara@yahoo.com
- Phone: 0722751501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.