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.
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
experimentalInterventions
- 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
- StatusCompleted
- PhasePhase IV
- Typeinterventional
- DesignRandomizedquadruple Blind
- Target Enrollment145 participants
- TimelineStart: 2015-06-05End: 2018-01-03
- Compound
- Topic