Dexmedetomidine After Cardiac Surgery for Prevention of Delirium

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

We designed a prospective, double blind, randomized, controlled versus placebo study to evaluate the efficacy of nightly low dose of Dexmedetomidine infusion to promote sleep and lower delirium in a population of post cardiac surgery patients. This population is characterized by longer ICU stay, more physical restraints such as catheters and drains, pain and sleep deprivation. It is associated with higher prevalence of Delirium and agitation leading to exposure to severe agitation related adverse events.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Brest
• Collaborators: Baxter Healthcare Corporation; Direction Générale de l'Offre de Soins
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• patients aged 65 or more who undergo cardiac surgery on and off-pump: coronary artery bypass graft, cardiac valve replacement or both.

• Consent signed

Exclusion Criteria:

• history of mental illness, dementia

• inclusion in another study evaluating sedation or pain

• length of stay in ICU less than 24 hours

• alpha 2 agonists allergy

• surgery performed in an immediate emergency situation

• uncontrolled hypotension

• second and third degree atrioventricular block without pacemaker

• severe hepatic insufficiency

• acute cerebrovascular diseases

• patient treated with clonidine

• patient with disturbed preoperative liver assessment (hepatocellular insufficiency)

• patient under guardianship or curatorship