Nociception monitoring during on-pump coronary artery bypass surgery
Feasibility Study of the Nociception Level (NOL) Index for Intraoperative Assessment of Nociception During Cardiac Surgery
This trial will test whether using a nociception (NOL) monitor during on-pump coronary artery bypass surgery helps guide pain control for adults under general anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT06817005 on ClinicalTrials.gov |
What this trial studies
Adult patients undergoing on-pump coronary artery bypass grafting will have intraoperative nociception monitored using the Nociception Level (NOL) index. Analgesic management will be guided by NOL signals with the goal of avoiding both insufficient and excessive opioid dosing. Investigators will record intraoperative hemodynamics, perioperative opioid consumption, and early postoperative pain outcomes. The study focuses on immediate physiological responses to surgical nociceptive stimuli and their relation to analgesic titration.
Who should consider this trial
Good fit: Adults scheduled for on-pump coronary artery bypass grafting without preoperative arrhythmia, pacemaker, advanced peripheral artery disease, preoperative shock, or concurrent participation in another interventional study are ideal candidates.
Not a fit: Patients with preoperative cardiac arrhythmias, implanted pacemakers, emergency surgery, stage 2 peripheral artery disease, preoperative shock, or those enrolled in another interventional research would be excluded and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce inappropriate opioid dosing during surgery and lower the risk of severe acute and possibly chronic postoperative pain.
How similar studies have performed: Prior studies in non-cardiac surgery using the NOL index have shown reduced intraoperative opioid use and improved hemodynamic control, but its application specifically in on-pump cardiac surgery remains less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * adult patients * patients undergoing on-pump cardiac surgery * specific cardiac procedure : coronary artery bypass grafting Exclusion criteria: * patients with preoperative cardiac arrhythmia * patients with a cardiac pacemaker * emergency cardiac surgical procedure * peripheral artery disease stage 2 * patients in shock prior to the cardiac surgery : mean arterial pressure 65mmHg with vasopressors * persons participating in another interventional research * patient refusal
Where this trial is running
Strasbourg
- Service d'Anesthésie Réanimation Cardiovasculaire — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Walid OULEHRI, MD
- Email: walid.oulehri@chru-strasbourg.fr
- Phone: 03.69.55.12.71
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.