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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00226876
Registration number
NCT00226876
Ethics application status
Date submitted
26/09/2005
Date registered
27/09/2005
Date last updated
30/05/2013
Titles & IDs
Public title
Dreaming During Anaesthesia and Anaesthetic Depth
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Scientific title
Dreaming During Anaesthesia and Anaesthetic Depth
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Secondary ID [1]
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2005/016
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anaesthesia
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion criteria
* Age 18-50 years
* American Society of Anesthesiologists physical status 1-3
* Non-cardiac surgery under relaxant general anaesthesia
* Tracheal extubation planned at end of surgery
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Inadequate English language skills (due to language barrier, cognitive deficit or intellectual disability)
* Major drug abuse or psychiatric condition
* Expected to be unable to co-operate or be available for followup
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2006
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Sample size
Target
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Accrual to date
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Final
300
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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Royal Melbourne Hospital - Melbourne
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Recruitment hospital [2]
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King Edward Memorial Hospital for Women - Perth
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Recruitment hospital [3]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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3050 - Melbourne
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Recruitment postcode(s) [2]
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6000 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
Melbourne Health
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Australian and New Zealand College of Anaesthetists
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Patients commonly report that they have been dreaming when they awaken from general anaesthesia. Our hypothesis is that patients who report dreaming are less deeply anaesthetised during anaesthesia than patients who do not report dreaming. Depth of anaesthesia will be determined using a processed electroencephalographic monitor (called the BIS monitor).
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Trial website
https://clinicaltrials.gov/study/NCT00226876
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Kate Leslie, MD
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Address
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Melbourne Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00226876
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