Opioid-Free Anesthesia in Cardiac Surgery

Phase 1

• Conditions: Patients undergoing cardiac surgery under extracorporeal circulation with at least one aorto-coronary bypass and the removal of at least one internal mammary artery; MedDRA version: 21.1Level: PTClassification code 10066124Term: Extracorporeal circulationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: LLTClassification code 10017501Term: Functional disturbances following cardiac surgerySystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-002126-90-FR
• Lead Sponsor: Direction de la Recherche Clinique et de l’Innovation – CHU de Rouen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-17
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 268

Inclusion Criteria

- Major patients between 18 and 75 years of age;
- Patients with Surgery programmed under extracorporeal circulation, with at least one aorto-coronary bypass and harvesting of at least one internal mammary artery; possible association with aortic valve replacement
- Patient who has read and understood the information letter and signed the consent form
- For women :
* of child-bearing age, need for confirmation of the absence of active pregnancy by a negative blood pregnancy test within 48 hours prior to inclusion.
* postmenopausal (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)
- Patient affiliated to a social security system
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 68

Exclusion Criteria

- Preoperative treatment with morphine or its derivatives (including tramadol) within 15 days prior to the inclusion visit.
- Pre-existing high degree of conduction disorder without apparatus
- Oxygen therapy prior to inclusion
- Heart failure with LVEF < 40%.
- IMC = 35
- Myocardial suffering in the 5 days prior to inclusion
- Patient in shock
- Known adrenal insufficiency and/or long-term systemic corticosteroid treatment (equivalent to hydrocortisone hemisuccinate = 20 mg/d)
- Mixed surgery other than aortic valve surgery
- Long-term non-invasive ventilation (including for obstructive sleep apnea syndrome)
- Any history or active practice(s) of substance abuse;
- Contraindication to any 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 completed (e.g. deaf patients),
- Pregnant or breastfeeding woman
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / subtutorship or guardianship
- Patient participating in another drug trial or having participated in another drug trial within 4 months prior to randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified