Plain English Summary
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 peoples 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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mary Stocker
ORCID ID
Contact details
Department of Anaesthetics
Torbay Hospital
Torquay
TQ2 7AA
United Kingdom
+44 (0)1803 614567
mary.stocker@nhs.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PRS09 version 1.0
Study information
Scientific title
Patient recall ability in the recovery ward following general anaesthesia: a quantitative case-control study in day case surgery
Acronym
Study hypothesis
The 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
North Somerset & South Bristol Research & Ethics Committee, 17/06/2009, Ref: 09/HO106/52
Study design
Randomised quantitative case-control single-centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Patient recall ability in the recovery ward following general anaesthesia
Intervention
In 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 type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Number of objects remembered.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
02/11/2009
Overall trial end date
19/11/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients at the Day Surgery Unit at Torbay Hospital
2. Both males and females, between the ages of 17 and 69 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300 (100 in each group)
Participant exclusion criteria
1. 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
Recruitment start date
02/11/2009
Recruitment end date
19/11/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthetics
Torquay
TQ2 7AA
United Kingdom
Sponsor information
Organisation
South Devon Healthcare NHS Foundation Trust (UK)
Sponsor details
c/o Fiona Roberts
Research and Development Department
Torbay Hospital
Torquay
TQ2 7AA
United Kingdom
+44 (0)1803 614567
fiona.roberts@nhs.net
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Torbay Hospital (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21883127
Publication citations
-
Results
Blandford CM, Gupta BC, Montgomery J, Stocker ME, Ability of patients to retain and recall new information in the post-anaesthetic recovery period: a prospective clinical study in day surgery., Anaesthesia, 2011, 66, 12, 1088-1092, doi: 10.1111/j.1365-2044.2011.06861.x.