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Dexmedetomidine for the Treatment of Delirium After Heart Surgery (DexinDelir)

This study has been terminated.
(Slow recruitment)
Information provided by:
Thorax-Kärlkliniken Identifier:
First received: June 7, 2010
Last updated: January 25, 2012
Last verified: March 2010

June 7, 2010
January 25, 2012
May 2010
May 2012   (final data collection date for primary outcome measure)
Need for rescue medication [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01140529 on Archive Site
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Dexmedetomidine for the Treatment of Delirium After Heart Surgery
A Prospective, Multi-centre, Randomised, Double-blind, Placebo-controlled Comparison of Intravenous Dexmedetomidine and Haloperidol in Treatment of Psychomotor Confusion After Heart Surgery

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.

Not Provided
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Postoperative
  • Delirium
  • Psychomotor
  • Confusion
  • Drug: Dexmedetomidine
    Bolus and continuous infusion
    Other Name: Precedex
  • Drug: Haloperidol
    Bolus doses
    Other Name: Haldol
  • Drug: Saline
    Bolus and continuous infusion
    Other Name: Vehicle
  • Experimental: Dexmedetomidine
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: Haloperidol
    Intervention: Drug: Haloperidol
  • Placebo Comparator: Placebo
    Intervention: Drug: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2012
May 2012   (final data collection date for primary outcome measure)

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
65 Years and older
Contact information is only displayed when the study is recruiting subjects
Sten Walther, ThoraxKärlkliniken, Universitetssjukhuset, Linköping
Not Provided
Principal Investigator: Sten M Walther, MD PhD ThoraxKärlkliniken, University Hospital, Linköping, Sweden
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP