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Rivastigmine for the Prevention of Postoperative Delirium in Patients Undergoing Cardiac Surgery

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: NCT00257868
Recruitment Status : Completed
First Posted : November 23, 2005
Last Update Posted : July 31, 2007
Information provided by:
University Hospital, Basel, Switzerland

Brief Summary:
The purpose of this study is to determine whether Rivastigmine is effective for the prevention of postoperative delirium in patients undergoing cardiac surgery.

Condition or disease Intervention/treatment Phase
Delirium Drug: Rivastigmine prevention of delirium Phase 3

Detailed Description:

Postoperative delirium is a frequent complication after cardiac surgery. In the literature an incidence ranging from 0 - 72 % is reported. The aetiology of this complication is multifactorial. A decline in cerebral cholinergic transmission as well as perioperative cerebral hypoperfusion or a systemic inflammatory response triggered by the extracorporeal circulation have been suspected. Advanced age is the most important patient-related risk factor. A perioperative delirium is an extremely unpleasant experience for the affected patients. Equally important is the fact that a delirium is associated with a prolonged length of stay on the intensive care unit and in hospital. Furthermore, patients who develop delirium have an increased six-month mortality. Recently successful treatment and prevention of the delirium with cholinesterase inhibitors such as rivastigmine have been reported.

The proposed study will test the hypothesis that prophylactically administered rivastigmine is able to prevent or at least reduce the symptoms of the postoperative delirium in elderly patients undergoing elective cardiac surgery with extracorporeal circulation.

This study is designed as a double blind randomised placebo controlled trial. Half the patients will receive placebo. The other half will receive rivastigmine 1.5m-1.5mg-1.5mg (oral solution), starting on the evening preceding the operation and for the first seven days postoperatively. Patients in both groups who develop delirium will be treated with a rescue medication consisting of lorazepam and haloperidol.

Measurements will include the incidence of delirium assessed using the Confusion Assessment Method (CAM). The severity of symptoms will by characterised by the Mini Mental Score and clock drawing. Further measurements will include the prescribed doses of rescue medication, the length of stay on intensive care and in hospital, the time of extracorporeal circulation, and laboratory parameters such as CRP, albumin, lymphocyte count, vitamin B12 and folic acid levels. Side effects of rivastigmine will be quantified.

The primary endpoint of this study is the incidence of delirium. Secondary endpoints will be the severity of delirium, the used doses of rescue medication, and length of stay (intensive care and hospital).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Rivastigmine for the Prevention of Postoperative Delirium After Cardiac Surgery
Study Start Date : January 2006
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Development of postoperative delirium within 7 days after cardiac surgery

Secondary Outcome Measures :
  1. Severity of delirium occurring within 7 days after cardiac surgery
  2. Length of stay (intensive care and hospital)
  3. Amount of drugs used for rescue therapy of delirium

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients undergoing cardiac surgery with use of extracorporeal circulation
  • Aged 65 or more

Exclusion Criteria:

  • "redo" procedures
  • anticipated use of succinylcholine during operation
  • contraindications to rivastigmine
  • preoperative mini mental score < 15

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): NCT00257868

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University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
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Principal Investigator: Luzius A Steiner, MD PhD Department of Anaesthesia, University Hospital Basel, Switzerland

Layout table for additonal information Identifier: NCT00257868     History of Changes
Other Study ID Numbers: EKBB 204/05
First Posted: November 23, 2005    Key Record Dates
Last Update Posted: July 31, 2007
Last Verified: July 2007

Additional relevant MeSH terms:
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Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents