Dexmedetomidine for the Treatment of Delirium After Heart Surgery
Information source: Thorax-Kärlkliniken
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative; Delirium; Psychomotor; Confusion
Intervention: Dexmedetomidine (Drug); Haloperidol (Drug); Saline (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Thorax-Kärlkliniken Official(s) and/or principal investigator(s):
Sten M Walther, MD PhD, Principal Investigator, Affiliation: ThoraxKärlkliniken, University Hospital, Linköping, Sweden
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-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.
Clinical Details
Official title: A Prospective, Multi-centre, Randomised, Double-blind, Placebo-controlled Comparison of Intravenous Dexmedetomidine and Haloperidol in Treatment of Psychomotor Confusion After Heart Surgery
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Need for rescue medication
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
ThoraxKärlkliniken, Linköping SE-61293, Sweden
Additional Information
Starting date: May 2010
Last updated: January 25, 2012
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