ISRCTN ISRCTN63108254
DOI https://doi.org/10.1186/ISRCTN63108254
Secondary identifying numbers PRS09 version 1.0
Submission date
13/05/2009
Registration date
02/07/2009
Last edited
22/08/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
In the UK a large percentage of surgery is now performed as day case procedures. On the day of their operation patients are often told new information before they are discharged home, for example about the findings of their operation. We wanted to look at how well patients can remember new verbal information in the period shortly after they have had a general anaesthetic and if the timing of when they are told this information has any effect on their ability to remember it.

Who can participate?
This trial was open to attenders of the Day Surgery Unit at Torbay Hospital aged between 18 and 69 years of age during the study period.

What does the study involve?
Patients in the study were randomly allocated into one of two groups: to either be given their recall test ‘early’ in their recovery period or ‘late’ in their recovery period. Patients were only tested once. We recruited a total of 200 patients so there were 100 in the ‘early testing’ group and 100 in the ‘late testing’ group. We also recruited another group of 100 people. These were people who were attending the day surgery unit but who were not receiving any general anaesthetic drugs during their visit. This third group took the same memory test to give a control group. Participants were given a simple verbal recall memory test. This involved being told five household objects to remember. They were then asked to name as many of these objects as they could remember after a period of 30 minutes. The items could be recalled in any order. The same memory test was used for each participant in the study.

What are the possible benefits & risks of participating?
The study will help us understand more about the length of time that anaesthetic drugs affect people’s ability to remember new information. This will help us change the timing and possibly the way we give new information after their anaesthetic to people having day surgery. There are no risks involved in this study. This study will not change any part of the treatment or care participants in the study receive.

Where is the study run from?
The Day Surgery Unit of Torbay Hospital, South Devon Healthcare NHS Foundation Trust (UK).

When is the study starting and how long is it expected to run for?
Data collection was performed in November 2009 and ended once 300 patients were recruited to the study. This took three weeks.

Who is funding the study?
No funding was required.

Who is the main contact?
Dr Mary Stocker, Consultant Anaesthetist & Director of Day Surgery. SDHCFT.
mary.stocker@nhs.net

Contact information

Dr Mary Stocker
Scientific

Department of Anaesthetics
Torbay Hospital
Torquay
TQ2 7AA
United Kingdom

Phone +44 (0)1803 614567
Email mary.stocker@nhs.net

Study information

Study designRandomised quantitative case-control single-centre study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePatient recall ability in the recovery ward following general anaesthesia: a quantitative case-control study in day case surgery
Study objectivesThe question we wish to address is whether patients who are recovering from general anaesthesia are able to recall information given to them in the immediate post-operative period, i.e., whilst in the primary recovery ward. Our hypothesis is that patients are able to recall information given to them in the recovery ward poorly. We also hypothesise that patients given information early in the recovery period remember this information poorly compared with patients given information later in the recovery period. The impetus for this study came from personal observations on the day surgery unit. We have noticed that patients are often given information by medical staff regarding the outcome of their surgery whilst on in the recovery ward. These patients are seemingly awake and orientated but often appear to have little recall of the information given to them at a later stage. As this verbal information may be the only information the patient is given regarding the outcome of their surgery failure to recall the discussion has consequences for patient satisfaction with respect to the day surgery process.

On 22/08/2013 the anticipated start date was changed from 01/07/2009 to 02/11/2009 and the anticipated end date was changed from 22/07/2009 to 19/11/2009.
Ethics approval(s)North Somerset & South Bristol Research & Ethics Committee, 17/06/2009, Ref: 09/HO106/52
Health condition(s) or problem(s) studiedPatient recall ability in the recovery ward following general anaesthesia
InterventionIn the arm of the trial involving patients in the primary recovery ward they will be given information to remember (5 objects - unrelated to surgery) when they fulfill the following criteria: opening eyes spontaneously, able to converse with staff, able to give date of birth. In the arm of the trial involving patients in the secondary recovery ward they will be given information 30 minutes after arriving in primary recovery. The control group of patients that have not had a general anaesthetic may be given the information at any time. All participants will be asked to recall the information 1 hour after being given it, no matter which arm of the trial they are in.
Intervention typeOther
Primary outcome measureNumber of objects remembered.
Secondary outcome measuresNo secondary outcome measures
Overall study start date02/11/2009
Completion date19/11/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants300 (100 in each group)
Key inclusion criteria1. Patients at the Day Surgery Unit at Torbay Hospital
2. Both males and females, between the ages of 17 and 69 years
Key exclusion criteria1. Patients with pre-existing medical conditions which may affect their memory
2. Patients whose recovery period is eventful, e.g., marked post-operative nausea and vomiting
3. Patients for whom English is not their first language will be excluded as this may affect their ability to recall information given to them
Date of first enrolment02/11/2009
Date of final enrolment19/11/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Anaesthetics
Torquay
TQ2 7AA
United Kingdom

Sponsor information

South Devon Healthcare NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Fiona Roberts
Research and Development Department
Torbay Hospital
Torquay
TQ2 7AA
England
United Kingdom

Phone +44 (0)1803 614567
Email fiona.roberts@nhs.net
Website http://www.sdhct.nhs.uk/
ROR logo "ROR" https://ror.org/05374b979

Funders

Funder type

Hospital/treatment centre

Torbay Hospital (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2011 Yes No