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

Phase 4

Completed

• Conditions: Depression; Delirium; Postoperative Cognitive Dysfunction; Anaesthesiology - Anaesthetics; Neurological - Dementias; Surgery - Other surgery

• Registration Number: ACTRN12615001074583
• Lead Sponsor: St Vincent's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-13
• Study Completion: 2019-07-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 145

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 & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure the incidence of delirium using the 3 minute Diagnostic Confusion Assessment Method (3D-CAM) in the perioperative period after cardiac and major vascular surgery in patients with baseline cognitive impairment receiving ketamine compared to placebo.[Neuropsychological testing at baseline (prior to surgery), Day 7 and 3 months postoperatively.];To measure the incidence of depression in patients with baseline cognitive impairment given ketamine compared to placebo, postoperatively and at 3 months following cardiac and major vascular surgery.[Neuropsychological assessment at baseline, day 7 and 3 months.]