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

This study has been terminated.
(Slow recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01140529
First Posted: June 9, 2010
Last Update Posted: November 1, 2016
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.
Information provided by (Responsible Party):
Sten Walther, Thorax-Kärlkliniken
  Purpose

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 Intervention Phase
Postoperative Delirium Psychomotor Confusion Drug: Dexmedetomidine Drug: Haloperidol Drug: Saline Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sten Walther, Thorax-Kärlkliniken:

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

Enrollment: 3
Study Start Date: May 2010
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01140529


Locations
Sweden
ThoraxKärlkliniken, Universitetssjukhuset
Linköping, Sweden, SE-58185
Sponsors and Collaborators
Thorax-Kärlkliniken
Investigators
Principal Investigator: Sten M Walther, MD PhD ThoraxKärlkliniken, University Hospital, Linköping, Sweden
  More Information

Responsible Party: Sten Walther, Dr, Thorax-Kärlkliniken
ClinicalTrials.gov Identifier: NCT01140529     History of Changes
Other Study ID Numbers: 3005099
First Submitted: June 7, 2010
First Posted: June 9, 2010
Last Update Posted: November 1, 2016
Last Verified: October 2016

Keywords provided by Sten Walther, Thorax-Kärlkliniken:
Dexmedetomidine

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Dexmedetomidine
Haloperidol
Haloperidol decanoate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
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
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs