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: 21.1 Level: PT Classification code 10066124 Term: Extracorporeal circulation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: LLT Classification code 10017501 Term: Functional disturbances following cardiac surgery System Organ Class: 100000004863
Conditions
Interventions
Trade Name: XYLOCARD 20 mg/ml
Product Name: Lidocaïne
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: LIDOCAINE
CAS Number: 137-58-6
Pharmaceutical form of the placebo: Solut
Sponsors
Direction de la Recherche Clinique et de l’Innovation – CHU de Rouen
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to show that a general anaesthesia strategy without the use of opioids (OFA) reduces the incidence of major opioid-related post-operative complications compared to the reference strategy using morphine;Secondary Objective: Assess the impact of OFA on the incidence of other post-operative complications: nausea-vomiting, pain, atrial and/or ventricular rhythm disorders, shock, acute renal failure, adrenal insufficiency, length of stay in intensive care and in hospital, mortality and the occurrence of other adverse events;Primary end point(s): Composite criteria consisting of the appearance within 48 hours postoperatively of at least one of the following events: - Intestinal ileus defined by the absence of digestive transit (gaseous or solid) or the appearance of an occlusive syndrome, objectified by the patient or the nursing staff. - Alteration of the neurological state by the appearance of a delusional syndrome or post-operative cognitive dysfunction. The latter is evaluated objectively using the CAM-ICU score. - Acute respiratory failure defined by one of the following criteria: need for oxygen therapy = 6L/min; use of ventilatory support (high-flow oxygen therapy, unplanned non-invasive ventilation, invasive ventilation with new orotracheal intubation); acute respiratory distress with signs of struggle; inability to wean off mechanical ventilation due to hypoxemia - Death;Timepoint(s) of evaluation of this end point: Within 48 hours postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): During the operating period : - Episode of bradycardia requiring urgent treatment (atropine, adrenaline, electro-systolic training, cardiac massage) - Hypertension requiring treatment (maximum systolic, mean and diastolic blood pressure, type of molecule used and dosage) - Hypotension requiring vasopressor treatment (minimum systolic, mean and diastolic blood pressure, type of molecule used and dosage) - Adverse events Within 48 hours postoperatively : - Existence of post-operative nausea-vomiting - Number of painful post-operative episodes at rest (EVA = 3) - Total consumption of morphine in mg evaluated by the use of a self-administration pump controlled by the patient. - Appearance of non-existing atrial fibrillation - Appearance of post-operative ventricular rhythm disorders (sustained ventricular tachycardia and/or ventricular fibrillation) - Presence of a vasoplegic syndrome defined by the need for intravenous norepinephrine for more than 4 hours. - Presence of cardiogenic shock defined by a cardiac index 2mmol/L, signs of acute heart failure and/or need for intravenous inotropes - Appearance of a high-grade conduction disorder - Post-operative myocardial suffering assessed by maximum troponinemia - Onset of acute renal failure defined by a KDIGO score = 1 - Incidence of relative adrenal insufficiency at 24 hours postoperatively with a synactene test. An elevation of cortisolaemia < 250 nmol/L within one hour after the injection of 250 g of tetracosactide is diagnostic. - Adverse events During the hospital stay - Appearance of a pneumopathy (infectious syndrome with signs of respiratory accompaniment and systematized radiological image) - Mechanical ventilation time - Length of stay in intensive care - Length of hospital stay - Hospital mortality - Adverse events;Timepoint(s) of evaluation of this end point: During operating periode for the endpoints 1 to 3 Within 48 hours postoperatively for the endpoints 4 to 14 | — |
Countries
France
Contacts
Public ContactDavid MALLET
Direction de la Recherche Clinique et de l’Innovation – CHU de Rouen
Outcome results
None listed