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

Brief 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.

Condition or disease Intervention/treatment Phase
Postoperative Delirium Psychomotor Confusion Drug: Dexmedetomidine Drug: Haloperidol Drug: Saline Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Dexmedetomidine Drug: Dexmedetomidine
Bolus and continuous infusion
Other Name: Precedex
Active Comparator: Haloperidol Drug: Haloperidol
Bolus doses
Other Name: Haldol
Placebo Comparator: Placebo Drug: Saline
Bolus and continuous infusion
Other Name: Vehicle

Primary Outcome Measures :
  1. Need for rescue medication [ Time Frame: 72 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01140529

ThoraxKärlkliniken, Universitetssjukhuset
Linköping, Sweden, SE-58185
Sponsors and Collaborators
Principal Investigator: Sten M Walther, MD PhD ThoraxKärlkliniken, University Hospital, Linköping, Sweden

Responsible Party: Sten Walther, Dr, Thorax-Kärlkliniken Identifier: NCT01140529     History of Changes
Other Study ID Numbers: 3005099
First Posted: June 9, 2010    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016

Keywords provided by Sten Walther, Thorax-Kärlkliniken:

Additional relevant MeSH terms:
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Haloperidol decanoate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs