Opioid-Free Anesthesia in Cardiac Surgery - OFACS

Direction de la Recherche Clinique et de l’Innovation – CHU de Rouen0 个研究点目标入组 268 人开始时间: 2020年12月17日最近更新: 2021年3月17日

适应症

试验速览

暂无简介。

•- 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

•- 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

发起方

Direction de la Recherche Clinique et de l’Innovation – CHU de Rouen