Dexmedetomidine for the Treatment of Delirium After Heart Surgery

• Status: Terminated
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary hypothesis: Dexmedetomidine is equal or superior to haloperidol and placebo in the treatment of psychomotor confusion in patients who are recovering from heart surgery.

Study design:

Multi-centre, prospective, randomised, placebo-controlled double-blind study of dexmedetomidine vs. haloperidol for treatment of psychomotor confusion after cardiac surgery. Data will be analyzed in two steps: The primary comparison is between placebo and dexmedetomidine. If the effect of dexmedetomidine is significant, a secondary comparison between dexmedetomidine and haloperidol will follow.

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

Details

• Lead Sponsor: Thorax-Kärlkliniken
• Treatments: Dexmedetomidine; Haloperidol; Haloperidol decanoate

Criteria

Inclusion Criteria:

• Age > 65 years

• Clinical need for treatment of psychomotor confusion unresponsive to standard analgesic medication (RASS +2 to +3)

• Heart surgery and extracorporeal circulation (ECC) within 7 days

• Written informed consent obtained before surgery

• Mentally competent at the time of written informed consent

Exclusion Criteria:

• Ongoing neuroleptic, propofol and α2 agonist medication

• Intubated patient

• Uncompensated acute circulatory failure at time of randomisation (severe hypotension with mean arterial pressure < 55 mmHg despite volume, vasopressors and IABP)

• Severe bradycardia without pacemaker backup (heart rate < 50 beats/min)

• AV-conduction block II-III (without pacemaker backup)

• Severe hepatic impairment (Serum bilirubin > 101 µmol/l)

• Lithium therapy