Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000279527
Ethics application status
Approved
Date submitted
28/06/2006
Date registered
4/07/2006
Date last updated
26/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Dreaming and EEG changes during anaesthesia maintained with propofol or desflurane
Scientific title
The incidence of dreaming and the nature of electroencephalographic (EEG) changes during anaesthesia maintained with propofol or desflurane
Secondary ID [1] 288010 0
Nil known
Universal Trial Number (UTN)
Trial acronym
GENIE II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dreaming during anaesthesia 1254 0
Condition category
Condition code
Anaesthesiology 1340 1340 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Control = continuous intravenous propofol infusion for maintenance of anaesthesia. Duration of administration and total dose will depend on duration of surgery.
Intervention code [1] 1174 0
Treatment: Drugs
Comparator / control treatment
Comparison = continuous inhaled desflurane for maintenance of anaesthesia. Duration of administration and total dose will depend on duration of surgery.
Control group
Active

Outcomes
Primary outcome [1] 1826 0
Incidence of dreaming during anaesthesia as evidence by self-report
Timepoint [1] 1826 0
At an immediate postoperative interview
Secondary outcome [1] 3200 0
Times to eye open
Timepoint [1] 3200 0
After cessation of anaesthetic administration, patients may first spontaneously open their eyes while they are still on the operating theatre or may not open their eyes until they are in the recovery room. Whenever the patient first opens their eyes, this will be recorded. This endpoint only happens once.
Secondary outcome [2] 3201 0
Orientation and recovery room discharge
Timepoint [2] 3201 0
Every 2 min after the patient opens their eyes they are assessed for orientation to time place and person. This endpoint will be recorded once only, on the first occasion that the patient is orientated. The time of recovery room discharge will be recorded once, when the patient leaves the recovery room.
Secondary outcome [3] 3202 0
EEG variables during maintenance of anaesthesia and during recovery.
Timepoint [3] 3202 0
Continuously during maintenance and recovery (data points every 1 min)

Eligibility
Key inclusion criteria
Presenting for relaxant general anaesthesia for non-cardiac surgery. Expected to be available for immediate postoperative interview.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with inadequate English language comprehension or major drug abuse problems.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed in opaque envelopes until consent has been obtained
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2006
Actual
16/08/2006
Date of last participant enrolment
Anticipated
Actual
1/02/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 1465 0
Charities/Societies/Foundations
Name [1] 1465 0
Australian and New Zealand College of Anaesthetists
Country [1] 1465 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Kate Leslie
Address
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Grattan St
Parkville Victoria 3050
Country
Australia
Secondary sponsor category [1] 1294 0
None
Name [1] 1294 0
Nil
Address [1] 1294 0
Country [1] 1294 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2846 0
Royal Melbourne Hospital
Ethics committee address [1] 2846 0
Ethics committee country [1] 2846 0
Australia
Date submitted for ethics approval [1] 2846 0
Approval date [1] 2846 0
16/08/2006
Ethics approval number [1] 2846 0
2006.125
Ethics committee name [2] 2847 0
Royal Perth Hospital
Ethics committee address [2] 2847 0
Ethics committee country [2] 2847 0
Australia
Date submitted for ethics approval [2] 2847 0
Approval date [2] 2847 0
Ethics approval number [2] 2847 0
Ethics committee name [3] 2848 0
King Edward Hospital for Women
Ethics committee address [3] 2848 0
Ethics committee country [3] 2848 0
Australia
Date submitted for ethics approval [3] 2848 0
Approval date [3] 2848 0
Ethics approval number [3] 2848 0
Ethics committee name [4] 2849 0
Waikato Hospital
Ethics committee address [4] 2849 0
Ethics committee country [4] 2849 0
New Zealand
Date submitted for ethics approval [4] 2849 0
Approval date [4] 2849 0
Ethics approval number [4] 2849 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35702 0
Prof Kate Leslie
Address 35702 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050
Australia
Country 35702 0
Australia
Phone 35702 0
+61-3-93427540
Fax 35702 0
Email 35702 0
[email protected]
Contact person for public queries
Name 10363 0
Kate Leslie
Address 10363 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050
Country 10363 0
Australia
Phone 10363 0
+61 3 93427540
Fax 10363 0
+61 3 93428623
Email 10363 0
[email protected]
Contact person for scientific queries
Name 1291 0
Kate Leslie
Address 1291 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050
Country 1291 0
Australia
Phone 1291 0
+61 3 93427540
Fax 1291 0
+61 3 93428623
Email 1291 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
Dimensions AIDetection of Burst Suppression Patterns in EEG Using Recurrence Rate2014https://doi.org/10.1155/2014/295070
N.B. These documents automatically identified may not have been verified by the study sponsor.