Status:
TERMINATED
Dexmedetomidine for the Treatment of Delirium After Heart Surgery
Lead Sponsor:
Thorax-Kärlkliniken
Conditions:
Postoperative
Delirium
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief 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-c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01140529
Start Date
May 1 2010
End Date
June 1 2012
Last Update
November 1 2016
Active Locations (1)
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1
ThoraxKärlkliniken, Universitetssjukhuset
Linköping, Sweden, SE-58185