Dexmedetomidine for the Treatment of Delirium After Heart Surgery (DexinDelir)

Thorax-Kärlkliniken

Status and phase

Terminated

Phase 3

Conditions

Delirium

Postoperative

Confusion

Psychomotor

Treatments

Drug: Dexmedetomidine

Drug: Haloperidol

Drug: Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT01140529

3005099

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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