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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00446212




Registration number
NCT00446212
Ethics application status
Date submitted
8/03/2007
Date registered
12/03/2007
Date last updated
30/05/2013

Titles & IDs
Public title
Dreaming and EEG Changes During Anaesthesia Maintained With Propofol or Desflurane
Scientific title
Dreaming and EEG Changes During Anaesthesia Maintained With Propofol or Desflurane
Secondary ID [1] 0 0
2006.125
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
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Propofol
Treatment: Drugs - desflurane

Active comparator: 1 - Propofol based anaesthetic maintenance with propofol effect-site steered target-controlled infusion, in addition to fentanyl and non-opioid analgesics

Active comparator: 2 - Desflurane based anaesthetic maintenance with manually controlled administration in 100% oxygen in addition to fentanyl and non-opioid analgesics


Treatment: Drugs: Propofol
target controlled infusion of propofol

Treatment: Drugs: desflurane
Anaesthetic maintenance with desflurane
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dreaming reported by patients interviewed immediately on emergence from anaesthesia using a standardised questionnaire
Timepoint [1] 0 0
recovery room stay

Eligibility
Key inclusion criteria
* Male and female patients
* Age between 18 and 50 years
* Presenting for elective surgery under general anaesthesia
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Inadequate English language comprehension
* Major drug abuse problem

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2008
Sample size
Target
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [2] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [3] 0 0
King Edward Memorial Hospital for Women - Subiaco
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment postcode(s) [2] 0 0
6000 - Perth
Recruitment postcode(s) [3] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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/NCT00446212