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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
Scientific title
Dreaming During Anaesthesia and Anaesthetic Depth
Secondary ID [1] 0 0
2005/016
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesia 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

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
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2006
Sample size
Target
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [2] 0 0
King Edward Memorial Hospital for Women - Perth
Recruitment hospital [3] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
3050 - Melbourne
Recruitment postcode(s) [2] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian and New Zealand College of Anaesthetists
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT00226876
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kate Leslie, MD
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00226876