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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00446212
Other study ID # 2006.125
Secondary ID
Status Completed
Phase Phase 4
First received March 8, 2007
Last updated May 28, 2013
Start date August 2006
Est. completion date July 2008

Study information

Verified date May 2013
Source Melbourne Health
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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.


Description:

Patients commonly report that they have been dreaming when they emerge from anaesthesia. Data from observational studies and small randomised trials suggests that reports of dreaming are more commonly made after anaesthesia maintained with propofol than anaesthesia maintained with inhaled anaesthetic agents. We propose to randomise 300 healthy patients to receive a standardised general anaesthetic for surgery that includes either propofol or desflurane for maintenance. We will measure the raw and processed electroencephalogram during and after anaesthesia and interview patients about dreaming as soon as they emerge from anaesthesia.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Male and female patients

- Age between 18 and 50 years

- Presenting for elective surgery under general anaesthesia

Exclusion Criteria:

- Inadequate English language comprehension

- Major drug abuse problem

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Drug:
Propofol
target controlled infusion of propofol
desflurane
Anaesthetic maintenance with desflurane

Locations

Country Name City State
Australia Royal Melbourne Hospital Parkville Victoria
Australia Royal Perth Hospital Perth Western Australia
Australia King Edward Memorial Hospital for Women Subiaco Western Australia
New Zealand Waikato Hospital Hamilton

Sponsors (1)

Lead Sponsor Collaborator
Melbourne Health

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of dreaming reported by patients interviewed immediately on emergence from anaesthesia using a standardised questionnaire recovery room stay No
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