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Dreaming and EEG Changes During Anaesthesia Maintained With Propofol or Desflurane

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ClinicalTrials.gov Identifier: NCT00446212
Recruitment Status : Completed
First Posted : March 12, 2007
Last Update Posted : May 30, 2013
Sponsor:
Information provided by (Responsible Party):
Melbourne Health

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.

Condition or disease Intervention/treatment Phase
Anaesthesia Drug: Propofol Drug: desflurane Phase 4

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Dreaming and EEG Changes During Anaesthesia Maintained With Propofol or Desflurane
Study Start Date : August 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Propofol based anaesthetic maintenance with propofol effect-site steered target-controlled infusion, in addition to fentanyl and non-opioid analgesics
Drug: Propofol
target controlled infusion of propofol
Active Comparator: 2
Desflurane based anaesthetic maintenance with manually controlled administration in 100% oxygen in addition to fentanyl and non-opioid analgesics
Drug: desflurane
Anaesthetic maintenance with desflurane



Primary Outcome Measures :
  1. Incidence of dreaming reported by patients interviewed immediately on emergence from anaesthesia using a standardised questionnaire [ Time Frame: recovery room stay ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446212


Locations
Australia, Victoria
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
King Edward Memorial Hospital for Women
Subiaco, Western Australia, Australia, 6008
New Zealand
Waikato Hospital
Hamilton, New Zealand
Sponsors and Collaborators
Melbourne Health
Investigators
Principal Investigator: Kate Leslie, MD Melbourne Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Melbourne Health
ClinicalTrials.gov Identifier: NCT00446212     History of Changes
Other Study ID Numbers: 2006.125
First Posted: March 12, 2007    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013

Keywords provided by Melbourne Health:
anaesthesia
propofol
desflurane
dreaming
electroencephalography

Additional relevant MeSH terms:
Anesthetics
Propofol
Desflurane
Isoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation