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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
We hypothesise that patients who receive propofol for maintenance of anaesthesia will report
dreaming more often when they emerge from anaesthesia than patients who receive desflurane
for maintenance of anaesthesia.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00446212
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 are available at https://clinicaltrials.gov/ct2/show/NCT00446212