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
  Purpose

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 Intervention Phase
Anaesthesia
Drug: Propofol
Drug: desflurane
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Dreaming and EEG Changes During Anaesthesia Maintained With Propofol or Desflurane

Resource links provided by NLM:


Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • 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 ]

Enrollment: 300
Study Start Date: August 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: 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
Other Name: desflurane

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Melbourne Health

Additional 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
Study First Received: March 8, 2007
Last Updated: May 28, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on April 17, 2014