Delirium Clinical Trial
— DexinDelirOfficial title:
A Prospective, Multi-centre, Randomised, Double-blind, Placebo-controlled Comparison of Intravenous Dexmedetomidine and Haloperidol in Treatment of Psychomotor Confusion After Heart Surgery
Verified date | October 2016 |
Source | Thorax-Kärlkliniken |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Läkemedelsverket |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | June 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
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 a2 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | ThoraxKärlkliniken, Universitetssjukhuset | Linköping |
Lead Sponsor | Collaborator |
---|---|
Thorax-Kärlkliniken |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Need for rescue medication | 72 hours | No |
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