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

July 30, 2007 updated by: University Hospital, Basel, Switzerland

Rivastigmine for the Prevention of Postoperative Delirium After Cardiac Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Development of postoperative delirium within 7 days after cardiac surgery

Secondary Outcome Measures

Outcome Measure
Severity of delirium occurring within 7 days after cardiac surgery
Length of stay (intensive care and hospital)
Amount of drugs used for rescue therapy of delirium

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Novartis

Investigators

  • Principal Investigator: Luzius A Steiner, MD PhD, Department of Anaesthesia, University Hospital Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

November 22, 2005

First Submitted That Met QC Criteria

November 22, 2005

First Posted (Estimate)

November 23, 2005

Study Record Updates

Last Update Posted (Estimate)

July 31, 2007

Last Update Submitted That Met QC Criteria

July 30, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKBB 204/05
  • CENA713CCH01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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