Opioid-Free Anesthesia for Heart Surgery

Opioid-Free Anesthesia in Cardiac Surgery

This study is testing whether using opioid-free anesthesia during heart surgery can help patients recover better and avoid problems linked to opioid use.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 268 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University Hospital, Rouen (Academic / other)
• Locations: 5 sites (Rouen, France, Normandy and 4 other locations)
• Trial ID: NCT04940689 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of opioid-free anesthesia (OFA) in patients undergoing cardiac surgery, specifically focusing on the use of dexmedetomidine and lidocaine compared to traditional opioid-based anesthesia. The study aims to assess the impact of OFA on postoperative complications associated with opioid use, such as cognitive dysfunction and pain management. By utilizing new analgesic agents that do not interact with opioid receptors, the trial seeks to improve patient outcomes and reduce the side effects commonly linked to opioids during and after surgery.

Who should consider this trial

Good fit: Ideal candidates include patients scheduled for cardiac surgery involving coronary artery bypass grafting and possibly aortic valve replacement.

Not a fit: Patients who have been treated with morphine or its derivatives in the 15 days prior to the study may not benefit from this trial.

Why it matters

Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve recovery for cardiac surgery patients.

How similar studies have performed: Previous studies have shown promising results with opioid-free anesthesia approaches in various surgical settings, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

* Patients having planned cardiac surgery under cardiopulmonary bypass, with at least one coronary artery bypass grafting and rf at least one internal mammary artery as graft; possible association with aortic valve replacement
* Patient having red and understood the information letter and signed the consent form
* For women : of childbearing age, need to confirm the absence of an active pregnancy by a negative blood pregnancy test within 48 hours prior to inclusion / menopausal (amenorrhea not medically induced for at least 12 months before the inclusion visit)
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Preoperative treatment with morphine or its derivatives (including tramadol) in the 15 days preceding the inclusion visit
* Pre-existing high-degree conduction disorder
* Bradycardia \< 50 bpm
* Oxygen therapy prior to inclusion
* Heart failure with LVEF \<40%
* BMI ≥ 35 kg/m²
* Myocardial suffering in the 5 days preceding inclusion
* Patient in shock
* Known adrenal insufficiency and / or long-term systemic corticosteroid treatment (equivalent to hydrocortisone hemisuccinate ≥ 20 mg / day)
* Combined surgery other than aortic valve
* Long-term non-invasive ventilation (including for obstructive sleep apnea syndrome)
* Any antecedent or active practice (s) of drug addiction;
* Contraindication to one of the experimental and / or non-experimental treatments: dexmedetomidine, lidocaine, dexamethasone, ketamine, remifentanil or morphine
* Acute cerebrovascular pathology,
* Severe hepatic insufficiency (factor V level \<50%),
* Pre-existing cognitive disorders,
* Patient for whom the CAM-ICU questionnaire cannot be carried out (deaf patients for example),
* Pregnant or parturient or breastfeeding woman
* Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / under guardianship or guardianship
* Patient participating in another drug trial or having participated in another drug trial within 1 month before randomization

Where this trial is running

Rouen, France, Normandy and 4 other locations

• Rouen University Hospital — Rouen, France, Normandy, France (Recruiting)
• Amiens Univesrity Hospital — Amiens, France (Recruiting)
• CAEN university Hospital — Caen, France (Not_yet_recruiting)
• Lille Hopistal University — Lille, France (Recruiting)
• Montpellier University Hospital — Montpellier, France (Recruiting)

Study contacts

• Study coordinator: Emmanuel Besnier, MD, PhD

Conditions Anesthesia