Postoperative hyperactive delirium MedDRA version: 12.0 Level: LLT Classification code 10000702 Term: Acute delirium MedDRA version: 12.0 Level: LLT Classification code 10049989 Term: Agitation postoperative MedDRA version: 12.0 Level: LLT Classification code 10056436 Term: Psychomotor agitation MedDRA version: 12.0 Level: LLT Classification code 10049987 Term: Confusion postoperative
Conditions
Interventions
Trade Name: Precedex
Product Name: Dexmedetomidine
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DEXMEDETOMIDINE
CAS Number: 113775476
Concentration unit: µg/ml micro
Sponsors
Sten Walther
Eligibility
Sex/Gender
All
Inclusion criteria
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
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] 101 µmol/l) - Lithium therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficency, assessed as need for rescue medication, of either dexmedetomidine, placebo or haloperidol in patients suffering from postoperative hyperactive delirium ;Secondary Objective: 1. Duration of confusion (time to medically fit for discharge) 2. Days of organ failure. SOFA score =3 (assessed daily during morning shifts) 3. Length of stay in the ICU/HDU (measured in hours) after meeting inclusion criteria 4. Nurses assessment of patient cooperation and communication (VAS) 5. Length of hospital stay (measured in days) 6. Costs of care in the ICU 7. Scores in ICU Memory tool and Impact of Event Scale (IES) 8. Serum levels of neuronal specific enolase (NSE);Primary end point(s): Need for rescue is defined as hyperactive delirium (RASS +1 to +4 dependning on time after inclusion, RASS = Richmond Agitation-Sedation Scale) unresponsive to non-pharmacological treatment and investigational drug/placebo given per protocol. Unresponsiveness is defined as hyperactive delirium (RASS+4) persisting 10 minutes after completion of bolus injection, or increasing hyperactive delirium during infusion of investigational drug/placebo (from RASS+1, RASS+2 or RASS +3). | — |
Countries
Sweden
Outcome results
None listed