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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01140529
Recruitment Status : Terminated (Slow recruitment)
First Posted : June 9, 2010
Last Update Posted : November 1, 2016
Information provided by (Responsible Party):
Sten Walther, Thorax-Kärlkliniken

June 7, 2010
June 9, 2010
November 1, 2016
May 2010
May 2012   (Final data collection date for primary outcome measure)
Need for rescue medication [ Time Frame: 72 hours ]
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.

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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
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*   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
Sexes Eligible for Study: All
65 Years and older   (Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Sten Walther, Thorax-Kärlkliniken
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Principal Investigator: Sten M Walther, MD PhD ThoraxKärlkliniken, University Hospital, Linköping, Sweden
October 2016

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