Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000307606
Ethics application status
Approved
Date submitted
30/08/2005
Date registered
6/09/2005
Date last updated
26/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Dreaming during anaesthesia and anaesthetic depth
Scientific title
Dreaming during anaesthesia and anaesthetic depth
Secondary ID [1] 288013 0
Nil known
Universal Trial Number (UTN)
Trial acronym
GENIE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dreaming during anaesthesia 395 0
Condition category
Condition code
Anaesthesiology 467 467 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study of anaesthetic depth in patients who do and do not report dreaming.
Intervention code [1] 303 0
Other interventions
Comparator / control treatment
No control group. Anaesthetic drugs chosen at discretion of anaesthetist.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 528 0
Anaesthetic depth
Timepoint [1] 528 0
Measured from anaesthetic induction until the first postoperative interview when patient responds to command
Secondary outcome [1] 1135 0
Quality of recovery
Timepoint [1] 1135 0
Measured at 2 hours and 24 hours postoperatively.

Eligibility
Key inclusion criteria
ASA 1-2, presenting for surgery under relaxant GA.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients without adequate English language comprehension, or who have major psychiatric or drug abuse problems excluded.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/01/2005
Actual
16/08/2006
Date of last participant enrolment
Anticipated
Actual
11/08/2008
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] 523 0
Other Collaborative groups
Name [1] 523 0
ANZCA
Country [1] 523 0
Australia
Primary sponsor type
Government body
Name
Melbourne Health
Address
Grattan St
Parkville Victoria 3050
Country
Australia
Secondary sponsor category [1] 426 0
None
Name [1] 426 0
None
Address [1] 426 0
Country [1] 426 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1504 0
Royal Melbourne Hospital
Ethics committee address [1] 1504 0
Parkville, VIC, 3050
Ethics committee country [1] 1504 0
Australia
Date submitted for ethics approval [1] 1504 0
Approval date [1] 1504 0
16/08/2006
Ethics approval number [1] 1504 0
2005.016
Ethics committee name [2] 1505 0
Royal Perth Hospital
Ethics committee address [2] 1505 0
Ethics committee country [2] 1505 0
Australia
Date submitted for ethics approval [2] 1505 0
Approval date [2] 1505 0
Ethics approval number [2] 1505 0
Ethics committee name [3] 1506 0
King Edward Memorial Hospital for Women
Ethics committee address [3] 1506 0
Ethics committee country [3] 1506 0
Australia
Date submitted for ethics approval [3] 1506 0
Approval date [3] 1506 0
Ethics approval number [3] 1506 0

Summary
Brief summary
Patients often report dreaming during general anaesthesia. However, it is not known whether patients who report dreaming are less deeply anaesthetised than patients who do not report dreaming. We therefore plan to compare anaesthetic depth in patients who do and do not report dreaming
Trial website
Trial related presentations / publications
LESLIE K, Skrzypek H, Paech MJ, Kurowski I, Whybrow T. Dreaming during anesthesia and anaesthetic depth in elective surgery patients: a prospective cohort study. Anesthesiology 2007; 106:33-42
Public notes

Contacts
Principal investigator
Name 35789 0
Prof Kate Leslie
Address 35789 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050
Australia
Country 35789 0
New Zealand
Phone 35789 0
+61-3-93427540
Fax 35789 0
Email 35789 0
[email protected]
Contact person for public queries
Name 9492 0
Mrs Associate Professor Kate Leslie
Address 9492 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050
Country 9492 0
Australia
Phone 9492 0
+61 3 93427000
Fax 9492 0
+61 3 93428623
Email 9492 0
[email protected]
Contact person for scientific queries
Name 420 0
Prof Associate Professor Kate Leslie
Address 420 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Parkville VIC 3050
Country 420 0
Australia
Phone 420 0
+61 3 93427000
Fax 420 0
+61 3 93428623
Email 420 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
No additional documents have been identified.