Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
09/07/06 v.1
Study information
Scientific title
Acronym
PROCEED
Study hypothesis
Post-operative cognitive decline (POCD) refers to the adverse neurological and neurocognitive changes that many individuals experience after surgery. The types of central nervous system impairments that are characteristic for POCD are short-term or long-term memory and attentional dysfunctions, disturbances in executive functioning and receptive language impairments.
The hypothesis of this trial is that twelve months post-operatively, overall cognitive performance and function on every day activities will be significantly more impaired in post-operative patients than in age matched controls
Ethics approval
Ethics approval received from the Kings College Hospital Research Ethics Committee on the 10th October 2006 (ref: 06/Q0703/168).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Post-operative cognitive decline (POCD)
Intervention
1. Bi-spectral index monitor (BIS): monitor of depth of anaesthesia
2. Somanetics invos cerebral oximeter (SICO): monitor of cerebral oxygen saturation
200 out of 250 participants will be patients undergoing surgery all of which will be given the above study interventions.
The remaining 50 participants will form the control group. These individuals will be age-matched control subject who will not undergo surgery. A non-surgical control group is needed in order to monitor the cognitive decline that occurs in this age group independent of surgical interventions in order to ensure that the potential postoperative cognitive decline is indeed due to the surgical intervention and associated procedures as opposed to naturally occuring age-related cognitive decline.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
1. The Cambridge Assessment for Mental Disorders in the Elderly (section B)
Secondary outcome measures
1. The Bristol Activities of Daily Living Scale
2. The Cornell depression scale
3. The Quality of Life instrument (EQ-5D, EuroQolGroup)
4. Cognitive Drug Research Battery (choice reaction time, simple reaction time, digit vigilance reaction time, number vigilance, visual working memory)
5. Client Service Receipt Inventory
6. Confusion Assessment Method
7. Trail-making A and B
8. Stroop Test
Overall trial start date
01/10/2006
Overall trial end date
01/10/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 65 years or over
2. Due to undergo major abdominal or orthopaedic surgery or a healthy relative of such a patient
3. Able to give informed consent
4. Fluency in English
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
250
Participant exclusion criteria
1. Mild cognitive impairment
2. Dementia
3. Physical disability which would interfere with cognitive interviewing (blindness, inability to write)
Recruitment start date
01/10/2006
Recruitment end date
01/10/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College London
London
SE1 1UL
United Kingdom
Funders
Funder type
Charity
Funder name
BUPA Foundation (UK) (Ref. No: NOV05/BALLARD18)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22719840
Publication citations
-
Results
Ballard C, Jones E, Gauge N, Aarsland D, Nilsen OB, Saxby BK, Lowery D, Corbett A, Wesnes K, Katsaiti E, Arden J, Amoako D, Amaoko D, Prophet N, Purushothaman B, Green D, Optimised anaesthesia to reduce post operative cognitive decline (POCD) in older patients undergoing elective surgery, a randomised controlled trial., PLoS ONE, 2012, 7, 6, e37410, doi: 10.1371/journal.pone.0037410.