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The effect of an orientation message on emergence agitation in adult surgical patients: a randomised controlled trial

The effect of an orientation message on emergence agitation in adult surgical patients: a randomised controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000287538
Enrollment
120
Registered
2024-03-20
Start date
2024-03-25
Completion date
2025-10-03
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

Royal Melbourne Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026