Clinical TrialDepressive DisordersKetamineCompleted

Perioperative Ketamine to Reduce Postoperative Delirium and Depression in elderly patients undergoing cardiac and major vascular surgery (The RECOGNISED Study)

This randomised controlled parallel group Phase IV trial (n=145) evaluated the safety and efficacy of ketamine for depression delirium postoperative cognitive dysfunction using 35mg/70kg ketamine.

Target Enrollment
145 participants
Study Type
Phase IV interventional
Design
Randomized, quadruple Blind

Detailed Description

This study aims to invesitgate the neuroprotective effects of ketamine in elderly patients undergoing cardiac and major vascular surgery. Delirium and depression are common effects of cardiac and major vascular surgery. Ketamine is believed to have a protective effect against delirium and depression. Participants will undergo neuropsychological testing prior to surgery and again at day 7 and 3 months postoperatively. Deliriuma and depression will be measured during patient hospital stay. Additionally, inflammatory bloods will be taken to assess the role inflammation plays in the role of postoperative cognitive dysfunction.

Study Arms & Interventions

Experimental Arm

experimental

Interventions

  • Ketamine

Participants

Inclusion Criteria

  • 1. Patients age 60 years or older, scheduled for cardiac or major vascular surgery (greater than 2 hours).
  • 2. Mini Mental State Examination score between 16 and 25
  • 3. Provide written and informed consent.
  • 4. Reside within reasonable prosimity to St Vincent's Hospital Melbourne for neuropsychological testing

Exclusion Criteria

  • 1. Prior neurological deficit (eg Stroke)
  • 2. Contraindication to neuropsychological testing such as language, visual or hearing impairment
  • 3. Associated medical problems that may lead to significant complications and subsequent loss to follow-up
  • 4. Anticipated ICU stay greater than 24 hours
  • 5. Patients on psychoactive drugs (not antidepressants)
  • 6. Patients unable to consent independently to their surgery on account of cognitive impairment.

Study Details

  • Status
    Completed
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment145 participants
  • Timeline
    Start: 2015-06-05
    End: 2018-01-03
  • Compound
  • Topic

Locations

Unknown facilityAustralia

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