Dexmedetomidine or clonidine infusion for prevention of delirium after open heart surgery

Phase 1

• Conditions: Postoperative delirium and cognitive decline in male and female participants aged 70+ scheduled for open heart surgery; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2021-001645-12-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-28
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:
•Participant must be =70 years old at the time of signing the informed consent.
•Participant must be accepted for cardiac surgery with cardiopulmonary bypass. The surgical procedures may constitute 1) coronary bypass grafting, 2) tricuspid, mitral, or aortic valve replacement or repair, 3) surgery on the ascending aorta, and 4) the combination of any of these procedures
•Participant must be capable of giving signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 900

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
• Preoperative delirium
• Known hypersensitivity to the active ingredient or components of the product
• Bradycardia due to sick-sinus-syndrome, 2nd or 3rd degree AV-block (if not treated with pacemaker) or any other reason causing HR <50 bpm at time of inclusion
• Ischemic stroke or transitory ischemic attack the last month or critical peripheral ischemia
• Acute coronary syndrome last 24 hours. Acute coronary syndrome is defined according to international guidelines
• Left ventricular ejection fraction < 40%
• Severe renal impairment with expected requirement for renal replacement therapy
• Severe hepatic dysfunction (liver enzyme three times the upper limit of normal together with a serum albumin concentration below the normal reference limit)
• Reduced peripheral autonomous activity (e.g. spinal cord injury)
• Current use of tricyclic antidepressants, monoamine reuptake inhibitors or ciclosporin
• Endocarditis or sepsis
• Planned deep hypothermia and circulatory arrest
• Emergency surgery, defined as less than 24 hours from admission to surgery
• Previously included in this study
• Not speaking or reading Norwegian
• Any other condition as evaluated by the treating physician

Study & Design

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