Dreaming and EEG Changes During Anaesthesia Maintained With Propofol or Desflurane
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | March 8, 2007 | ||||
| Last Updated Date | March 8, 2007 | ||||
| Start Date ICMJE | August 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Incidence of dreaming reported by patients interviewed immediately on emergence from anaesthesia using a standardised questionnaire | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Dreaming and EEG Changes During Anaesthesia Maintained With Propofol or Desflurane | ||||
| Official Title ICMJE | Dreaming and EEG Changes During Anaesthesia Maintained With Propofol or Desflurane | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 300 | ||||
| Completion Date | August 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Australia, New Zealand | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00446212 | ||||
| Other Study ID Numbers ICMJE | 2006.125 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Melbourne Health | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Melbourne Health | ||||
| Verification Date | March 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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