ISRCTN - ISRCTN63108254: Patient recall following general anaesthesia

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 type

Government

Website

http://www.sdhct.nhs.uk/

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