Last updated: February 23, 2024
Sponsor: University Hospital, Rouen
Overall Status: Active - Recruiting
Phase
3
Condition
Anesthesia
Treatment
Remifentanil
Dexmédétomidine 0.5 g/kg + lidocaine 1.5 mg/kg
Clinical Study ID
NCT04940689
2019/0399/HP
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients having planned cardiac surgery under cardiopulmonary bypass, with at leastone coronary artery bypass grafting and rf at least one internal mammary artery asgraft; 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 bya 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
Exclusion Criteria:
- Preoperative treatment with morphine or its derivatives (including tramadol) in the 15days 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 forexample),
- Pregnant or parturient or breastfeeding woman
- Person deprived of liberty by an administrative or judicial decision or person placedunder judicial protection / under guardianship or guardianship
- Patient participating in another drug trial or having participated in another drugtrial within 1 month before randomization
Study Design
Total Participants: 268
Treatment Group(s): 2
Primary Treatment: Remifentanil
Phase: 3
Study Start date:
July 22, 2021
Estimated Completion Date:
November 01, 2024
Study Description
Connect with a study center
Rouen University Hospital
Rouen, France, Normandy 76031
FranceActive - Recruiting
Amiens Univesrity Hospital
Amiens,
FranceActive - Recruiting
CAEN university Hospital
Caen,
FranceSite Not Available
Lille Hopistal University
Lille,
FranceActive - Recruiting
Montpellier University Hospital
Montpellier,
FranceActive - Recruiting
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