Dreaming and EEG Changes During Anaesthesia Maintained With Propofol or Desflurane

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00446212
First received: March 8, 2007
Last updated: May 28, 2013
Last verified: May 2013

March 8, 2007
May 28, 2013
August 2006
July 2008   (final data collection date for primary outcome measure)
Incidence of dreaming reported by patients interviewed immediately on emergence from anaesthesia using a standardised questionnaire [ Time Frame: recovery room stay ] [ Designated as safety issue: No ]
Incidence of dreaming reported by patients interviewed immediately on emergence from anaesthesia using a standardised questionnaire
Complete list of historical versions of study NCT00446212 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Dreaming and EEG Changes During Anaesthesia Maintained With Propofol or Desflurane
Dreaming and EEG Changes During Anaesthesia Maintained With Propofol or Desflurane

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Anaesthesia
  • Drug: Propofol
    target controlled infusion of propofol
    Other Name: propofol
  • Drug: desflurane
    Anaesthetic maintenance with desflurane
    Other Name: desflurane
  • Active Comparator: 1
    Propofol based anaesthetic maintenance with propofol effect-site steered target-controlled infusion, in addition to fentanyl and non-opioid analgesics
    Intervention: Drug: Propofol
  • Active Comparator: 2
    Desflurane based anaesthetic maintenance with manually controlled administration in 100% oxygen in addition to fentanyl and non-opioid analgesics
    Intervention: Drug: desflurane
Leslie K, Sleigh J, Paech MJ, Voss L, Lim CW, Sleigh C. Dreaming and electroencephalographic changes during anesthesia maintained with propofol or desflurane. Anesthesiology. 2009 Sep;111(3):547-55.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   New Zealand
 
NCT00446212
2006.125
No
Melbourne Health
Melbourne Health
Not Provided
Principal Investigator: Kate Leslie, MD Melbourne Health
Melbourne Health
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP