A prospective, multi-centre, randomised, double-blind, placebo-controlled comparison of intravenous dexmedetomidine with haloperidol in treatment of hyperactive delirium after heart surgery. - Dex-in-delir

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 75

Inclusion Criteria

- Age more than or equal to 65 years
- Clinical need for treatment of confusion/agitation unresponsive to standard analgesic medication (RASS +2 to +3, RASS = Richmond Agitation-Sedation Scale)
- Heart surgery and extracorporeal circulation (ECC) within 7 days
- Written informed consent obtained before surgery
- Mentally competent at the time of written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Ongoing neuroleptic, propofol and alpha-2 agonist medication
- Intubated patient
- Uncompensated acute circulatory failure at time of randomisation (severe hypotension with mean arterial pressure [MAP] < 55 mmHg despite volume, pressors and IABP)
- Severe bradycardia without pacemaker backup (heart rate [HR] < 50 beats/min)
- AV-conduction block II-III (without pacemaker backup)
- Severe hepatic impairment (bilirubin > 101 µmol/l)
- Lithium therapy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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