A prospective, randomised, controlled evaluation of the effects of optimisation of cerebral oxygenation and depth of anaesthesia on postoperative cognitive functioning in older patients undergoing major orthopaedic and abdominal surgery

ISRCTN	ISRCTN39503939
DOI	https://doi.org/10.1186/ISRCTN39503939
Protocol serial number	09/07/06 v.1
Sponsor	King's College London (UK)
Funder	BUPA Foundation (UK) (Ref. No: NOV05/BALLARD18)

Submission date: 10/07/2006
Registration date: 15/09/2006
Last edited: 24/09/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Clive Ballard
Scientific

King's College London
Guy's Campus
London
SE1 1UL
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PROCEED
Study objectives	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(s)	Ethics approval received from the Kings College Hospital Research Ethics Committee on the 10th October 2006 (ref: 06/Q0703/168).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. The Cambridge Assessment for Mental Disorders in the Elderly (section B)
Key secondary outcome measure(s)	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
Completion date	01/10/2009

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	250
Key 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
Key exclusion criteria	1. Mild cognitive impairment 2. Dementia 3. Physical disability which would interfere with cognitive interviewing (blindness, inability to write)
Date of first enrolment	01/10/2006
Date of final enrolment	01/10/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

King's College London

London
SE1 1UL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2012		Yes	No