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 |
| Secondary identifying numbers | 09/07/06 v.1 |
- 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
Scientific
King's College London
Guy's Campus
London
SE1 1UL
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/10/2006 |
| Completion date | 01/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
King's College London
London
SE1 1UL
United Kingdom
SE1 1UL
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
Guy's Campus
London
SE1 1UL
England
United Kingdom
"ROR" |
https://ror.org/0220mzb33 |
|---|
Funders
Funder type
Charity
BUPA Foundation (UK) (Ref. No: NOV05/BALLARD18)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
