Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001748808
Ethics application status
Approved
Date submitted
26/11/2021
Date registered
21/12/2021
Date last updated
21/12/2021
Date data sharing statement initially provided
21/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The day surgery sleep study
Scientific title
The Day Surgery Sleep Survey (DURESS) project: the effect of day surgery on sleep quantity and quality.
Secondary ID [1] 305898 0
Nil known
Universal Trial Number (UTN)
Trial acronym
DURESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep disturbance 324455 0
Condition category
Condition code
Anaesthesiology 321943 321943 0 0
Anaesthetics
Mental Health 322130 322130 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Brief name: a text message-based survey to follow-up post-operative sleep disruption.

Patients >18 years old undergoing non-cardiac day surgery at Wellington Hospital or Kenepuru Hospital who consent to participate in the study will have their cellphone number recorded for the text-based survey link. The first survey will be sent to each participant, 24 hours post-discharge, by text (or by email if there is no cellphone number) to their smartphone. If the patient responds to the first survey request, they will receive two further surveys, one on day 3 postoperatively, and one on day 7 postoperatively.
Intervention code [1] 322291 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329698 0
Sleep quantity – self reported, measured in hours. Assessed using a study-specific survey sent via text message.
Timepoint [1] 329698 0
On average in the month prior to the operation and on day 1, 3 and 7 postoperatively.
Primary outcome [2] 329699 0
Sleep quality – self reported, measured on an eleven-point numeric rating scale from 0 (worst) to 10 (best). Assessed using a study-specific survey sent via text message.
Timepoint [2] 329699 0
On average in the month prior to the operation and on day 1, 3 and 7 postoperatively.
Secondary outcome [1] 403501 0
Surgery type by specialty
Timepoint [1] 403501 0
Data collected at time of consent using daily hospital theatre lists
Secondary outcome [2] 403502 0
Time of induction of anaesthesia
Timepoint [2] 403502 0
On day of surgery - data collected using the SaferSleep platform after patient's participation in the survey.
Secondary outcome [3] 403503 0
Duration of anaesthesia
Timepoint [3] 403503 0
On day of surgery - data collected using the SaferSleep platform after patient's participation in the survey.
Secondary outcome [4] 403504 0
Type of anaesthesia – general, general and regional, regional and sedation, regional alone, sedation alone, other.
Timepoint [4] 403504 0
On day of surgery - data collected using the SaferSleep platform after patient's participation in the survey.
Secondary outcome [5] 403505 0
Specific medicines used intra-operatively (dose in mg) – benzodiazepines, dexmedetomidine, dexamethasone, opioids (morphine equivalents).
Timepoint [5] 403505 0
On day of surgery - data collected using the SaferSleep platform after patient's participation in the survey.
Secondary outcome [6] 403507 0
Postoperative pain – visual analogue scale from 0 (no pain) to 10 (extreme pain). Assessed using a study-specific survey sent via text message.
Timepoint [6] 403507 0
On day 1, 3 and 7 postoperatively.

Eligibility
Key inclusion criteria
Patients aged 18 years and older scheduled for elective day surgery under Capital Coast District Health Board (CCDHB).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any patients who are not discharged home on the same day as their surgery, if they have a known history of alcohol or drug abuse, diminished understanding or comprehension, poor English understanding, or were aged less than 18 years old on the day of surgery.

Study design
Purpose
Duration
Selection
Defined population
Timing
Both
Statistical methods / analysis
As there is currently no known level of sleep disruption deemed to be clinically significant no formal hypothesis test will be undertaken. Rather, differences in mean (or median if data is non-parametric) sleep quantity and quality will be assessed independently between pre-operative values and values obtained on post-operative days 1, 3, and 7 with a point estimate and attendant 95% confidence interval. An interval that crosses the null value (a difference of 0 hours in the case of sleep quantity, and a difference of 0cm in the case of sleep quality) would be deemed insufficient evidence to conclude there is a difference in that outcome on that post-operative night compared to pre-operative values.

Two separate multivariate linear models will be used to investigate the association between the other variables collected and sleep quality and quantity.

No correction will be made for multiple testing as the aim of this study is hypothesis generation; conclusions should therefore be treated as such.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/12/2021
Date of last participant enrolment
Anticipated
25/02/2022
Actual
Date of last data collection
Anticipated
4/03/2022
Actual
Sample size
Target
400
Accrual to date
88
Final
Recruitment outside Australia
Country [1] 24351 0
New Zealand
State/province [1] 24351 0
Wellington Region

Funding & Sponsors
Funding source category [1] 310245 0
Charities/Societies/Foundations
Name [1] 310245 0
Campbell Barrett Trust
Country [1] 310245 0
New Zealand
Funding source category [2] 310246 0
Hospital
Name [2] 310246 0
Department of Anaesthesia and Pain Medicine, Wellington Hospital
Country [2] 310246 0
New Zealand
Funding source category [3] 310248 0
University
Name [3] 310248 0
Eru Pomare Maori Health Research Centre, University of Otago, Wellington
Country [3] 310248 0
New Zealand
Primary sponsor type
Individual
Name
Dr Daniel Ramsay
Address
Department of Anaesthesia and Pain Medicine, Wellington Hospital, 49 Riddiford Street, Newtown, Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 311348 0
Individual
Name [1] 311348 0
Dr Phillip Quinn
Address [1] 311348 0
Department of Anaesthesia and Pain Medicine, Wellington Hospital, 49 Riddiford Street, Newtown, Wellington 6021
Country [1] 311348 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309924 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 309924 0
Ministry of Health,
133 Molesworth Street
PO Box 5013
Wellington, 6011
Ethics committee country [1] 309924 0
New Zealand
Date submitted for ethics approval [1] 309924 0
04/10/2021
Approval date [1] 309924 0
30/11/2021
Ethics approval number [1] 309924 0

Summary
Brief summary
Sleep disturbance appears to be nearly universal post-operatively, and has been associated with increased rates of delirium, pain, cardiovascular events, and longer recovery times. In spite of current research there remains uncertainty as to the degree and duration of sleep disruption postoperatively. In addition, the role, if any, that pharmacological agents commonly used in anaesthesia have on postoperative sleep disturbance is yet to be fully elucidated. This study aims to explore the utility of a text message based survey to study perioperative sleep disruption in day surgery patients. If a text message-based method for following up postoperative sleep disruptions can be shown to be effective, this will allow for larger scale research utilising this approach.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115854 0
Dr Daniel Ramsay
Address 115854 0
Department of Anaesthesia and Pain Medicine, Wellington Hospital, 49 Riddiford Street, Newtown, Wellington 6021
Country 115854 0
New Zealand
Phone 115854 0
+64 27 536 2649
Fax 115854 0
Email 115854 0
[email protected]
Contact person for public queries
Name 115855 0
Dr Daniel Ramsay
Address 115855 0
Department of Anaesthesia and Pain Medicine, Wellington Hospital, 49 Riddiford Street, Newtown, Wellington 6021
Country 115855 0
New Zealand
Phone 115855 0
+64 27 536 2649
Fax 115855 0
Email 115855 0
[email protected]
Contact person for scientific queries
Name 115856 0
Dr Daniel Ramsay
Address 115856 0
Department of Anaesthesia and Pain Medicine, Wellington Hospital, 49 Riddiford Street, Newtown, Wellington 6021
Country 115856 0
New Zealand
Phone 115856 0
+64 27 536 2649
Fax 115856 0
Email 115856 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All unidentified patient data
When will data be available (start and end dates)?
Following publication, no end date
Available to whom?
Researchers undertaking further studies in the field (e.g. meta-analyses)
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
Access subject to approval by the Principal Investigator (Dr Daniel Ramsay, 027 536 2649, [email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14230Study protocol    383199-(Uploaded-26-11-2021-08-38-46)-Study-related document.docx



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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