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. 2022 Jun 20;12(6):e057460. doi: 10.1136/bmjopen-2021-057460

Table 1.

Inclusion and exclusion criteria

Participants are eligible to be included in the study only if all of the following criteria apply: Participants are excluded from the study if any 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.

  • Preoperative delirium (present at time of potential inclusion).

  • Known hypersensitivity to the active ingredient or components of the product.

  • Bradycardia due to sick sinus syndrome, second-degree or third-degree AV-block (if not treated with pacemaker) or any other reason causing HR <50 bpm at time of inclusion.

  • Uncontrolled hypotension.

  • Ischaemic stroke or transitory ischaemic attack the last month or critical peripheral ischaemia.

  • Acute coronary syndrome last 24 hours. Acute coronary syndrome is defined according to international guidelines.

  • Left ventricular ejection fraction <40%.

  • Severe renal impairment (eGFR <20 mL/min) or 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 (eg, spinal cord injury).

  • Current use of tricyclic antidepressants, monoamine reuptake inhibitors or ciclosporin.

  • Endocarditis or sepsis.

  • Pheochromocytoma.

  • Planned deep hypothermia and circulatory arrest.

  • Emergency surgery, defined as <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.

AV-block, atrioventricular block; eGFR, estimated glomerular filtration rate; HR, heart rate.