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Trial registered on ANZCTR


Registration number
ACTRN12624000287538
Ethics application status
Approved
Date submitted
21/02/2024
Date registered
20/03/2024
Date last updated
20/03/2024
Date data sharing statement initially provided
20/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of an orientation message on emergence agitation in adult surgical patients: a randomised controlled trial
Scientific title
The effect of an orientation message on emergence agitation in adult surgical patients: a randomised controlled trial
Secondary ID [1] 311587 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emergence agitation 332971 0
Condition category
Condition code
Anaesthesiology 329683 329683 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Orientation message and verbal command ((‘(Patient’s name), you are waking up in the Royal Melbourne Hospital after your surgery, please open your eyes’) played via noise-cancelling headphones at conversational volume and repeated after a 5-s pause. The intervention will be administered in the operating room from the cessation of anaesthetic administration until the patient opens their eyes. Adherence to the intervention will be monitored by a blinded investigator.
Intervention code [1] 328042 0
Prevention
Comparator / control treatment
Verbal command (‘(Patient’s name), please open your eyes’) played via noise-cancelling headphones at conversational volume and repeated after a 5-s pause. The intervention will be administered in the operating room from the cessation of anaesthetic administration until the patient opens their eyes. Adherence to the intervention will be monitored by a blinded investigator.
Control group
Active

Outcomes
Primary outcome [1] 337469 0
Emergence agitation in the operating room
Timepoint [1] 337469 0
Continuously assessed from cessation of anaesthetic administration until the patient leaves the operating room. The blinded investigator will record the scale score at anaesthetic cessation and the new score every time there is a change.
Secondary outcome [1] 431993 0
Dangerous emergence agitation in the operating room
Timepoint [1] 431993 0
Continuously assessed from cessation of anaesthetic administration until the patient leaves the operating room. The blinded investigator will record the scale score at anaesthetic cessation and the new score every time there is a change.
Secondary outcome [2] 431994 0
Maximum emergence agitation in the operating room
Timepoint [2] 431994 0
Continuously assessed from cessation of anaesthetic administration until the patient leaves the operating room. The blinded investigator will record the scale score at anaesthetic cessation and the new score every time there is a change.
Secondary outcome [3] 431995 0
Emergence agitation in the post anaesthesia care unit
Timepoint [3] 431995 0
Continuously assessed from admission to the post anaesthesia care unit to discharge from the post anaesthesia care unit. The blinded investigator will record the scale score at admission and the new score every time there is a change.
Secondary outcome [4] 431996 0
Dangerous emergence agitation in the post anaesthesia care unit
Timepoint [4] 431996 0
Continuously assessed from admission to the post anaesthesia care unit to discharge from the post anaesthesia care unit. The blinded investigator will record the scale score at admission and the new score every time there is a change.
Secondary outcome [5] 431997 0
Maximum emergence agitation in the post anaesthesia care unit
Timepoint [5] 431997 0
Continuously assessed from admission to the post anaesthesia care unit to discharge from the post anaesthesia care unit. The blinded investigator will record the scale score at admission and the new score every time there is a change.
Secondary outcome [6] 431998 0
Delirium in the post anaesthesia care unit
Timepoint [6] 431998 0
At discharge from the post anaesthesia care unit
Secondary outcome [7] 431999 0
Delirium on postoperative day 1
Timepoint [7] 431999 0
On the morning of postoperative day 1

Eligibility
Key inclusion criteria
1. Aged greater than or equal to 18 years
2. Plan for elective or expedited non-cardiac surgery
3. Plan for relaxant general anaesthesia with an endotracheal tube
4. Minor to moderate complexity surgery
5. Expected hospital stay of greater than or equal to 1 postoperative night
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability to provide written informed consent (e.g., language barrier, intellectual disability, cognitive deficit, urgent surgery)
2. Inability to apply headphones (e.g., ear surgery, cranial surgery)
3. Inability to hear or comprehend recorded message (e.g., language barrier, intellectual disability, cognitive deficit, hearing impairment)
4. Plan to remain intubated and sedated after leaving the operating room
5. Previously randomised to the trial

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consecutive numbered opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Web-based
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
18/03/2025
Actual
Date of last data collection
Anticipated
19/03/2025
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315894 0
Hospital
Name [1] 315894 0
The Royal Melbourne Hospital
Country [1] 315894 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Country
Australia
Secondary sponsor category [1] 318038 0
None
Name [1] 318038 0
Address [1] 318038 0
Country [1] 318038 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314738 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 314738 0
https://www.thermh.org.au/research/researchers/ethics
Ethics committee country [1] 314738 0
Australia
Date submitted for ethics approval [1] 314738 0
23/06/2023
Approval date [1] 314738 0
06/09/2023
Ethics approval number [1] 314738 0

Summary
Brief summary
Agitation commonly occurs on emergence from general anaesthesia in adult patients. Our hypothesis is that an orientation message and verbal command will be superior to a verbal command alone. The messages will be delivered via noise-cancelling headphones from cessation of general anaesthesia until the patient opens their eyes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132570 0
Dr Linda Mattheyse
Address 132570 0
Royal Melbourne Hospital, 300 Grattan St, Parkville, VIC, 3052
Country 132570 0
Australia
Phone 132570 0
+61 3 93427540
Fax 132570 0
Email 132570 0
linda.mattheyse2@mh.org.au
Contact person for public queries
Name 132571 0
Linda Mattheyse
Address 132571 0
Royal Melbourne Hospital, 300 Grattan St, Parkville, VIC, 3052
Country 132571 0
Australia
Phone 132571 0
+61 3 93427540
Fax 132571 0
Email 132571 0
linda.mattheyse2@mh.org.au
Contact person for scientific queries
Name 132572 0
Linda Mattheyse
Address 132572 0
Royal Melbourne Hospital, 300 Grattan St, Parkville, VIC, 3052
Country 132572 0
Australia
Phone 132572 0
+61 3 93427540
Fax 132572 0
Email 132572 0
linda.mattheyse2@mh.org.au

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 deidentified data
When will data be available (start and end dates)?
One year after publication of the main result until 5 years after publication of the main result.
Available to whom?
Anaesthesia researchers
Available for what types of analyses?
Individual patient data meta-analyses
How or where can data be obtained?
By contacting the chief investigator (linda.mattheyse2@mh.org.au)


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.