Condition category
Surgery
Date applied
10/07/2006
Date assigned
15/09/2006
Last edited
24/09/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Clive Ballard

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Guy's Campus
London
SE1 1UL
United Kingdom

Sponsor type

University/education

Website

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

foundation

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22719840

Publication citations

  1. 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.

Additional files

Editorial Notes