CompletedPhase 4ACTRN12615001074583

Perioperative Ketamine to Reduce Postoperative Delirium and Depression - The RECOGNISED Study

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


Sponsor

St Vincent's Hospital

Enrollment

145 participants

Start Date

Jun 5, 2015

Study Type

Interventional

Conditions

Summary

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.


Eligibility

Sex: Both males and femalesMin Age: 60 Yearss

Inclusion Criteria4

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

Exclusion Criteria6

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

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Interventions

Participants involved in study will be randomly assigned to either a ketamine group or a control group before undergoing cardiac or major vascular surgery. Ketamine is proposed as a neuroprotective dr

Participants involved in study will be randomly assigned to either a ketamine group or a control group before undergoing cardiac or major vascular surgery. Ketamine is proposed as a neuroprotective drug from delirium and depression postoperatively as they are a common in the elderly population undergoing cardiac and major vascular surgery. Ketamine/saline will be administered intravenously as a single dose (0.5mg/kg) fifteen minutes following anaesthetic induction. No further alterations or additions to anaesthetic or surgical technique are required.


Locations(1)

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

VIC, Australia

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ACTRN12615001074583


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