ACTRN12615001074583CompletedPhase 4
Perioperative Ketamine to Reduce Postoperative Delirium and Depression in elderly patients undergoing cardiac and major vascular surgery (The RECOGNISED Study)
St Vincent's Hospital0 sites145 target enrollmentStarted: October 13, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 145
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Prevention
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 60 Years to o limit (—)
- Sex
- All
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.
Investigators
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