Dexmedetomidine for the Treatment of Delirium After Heart Surgery

Phase 3TerminatedNCT01140529

Thorax-Kärlkliniken3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Postoperative Delirium Psychomotor Confusion

Interventions

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Dexmedetomidine for the Treatment of Delirium After Heart Surgery

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes