Long-term Outcome of General Anesthesia on Dysgnosia (LOGAND)
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| First Received Date ICMJE | August 16, 2010 | ||||||||
| Last Updated Date | May 10, 2011 | ||||||||
| Start Date ICMJE | August 2010 | ||||||||
| Estimated Primary Completion Date | August 2020 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Cognitive ability [ Time Frame: The 10th year since postoperation ] [ Designated as safety issue: Yes ] Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01184638 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Long-term Outcome of General Anesthesia on Dysgnosia | ||||||||
| Official Title ICMJE | Long-term Outcome Followed-up of the Cognitive Disorders After General Anesthesia | ||||||||
| Brief Summary | Cognitive disorders in patients underwent general anesthesia are discussed for decades, but whether there were precise relationship between general anesthesia and dysgnosia is yet to be guaranteed. Although controversial data reported from experimental studies in animals, the investigators still proposed that general anesthetics could impair the normally organized system of the central nervous system, which finally displayed a dysfunction of cognition after general anesthesia in a short- or long-term period. Therefore, different types of general anesthetics such as inhalational anesthetics and intravenous anesthetics, the investigators hypothesized, had a long-term influence on patients' cognitive ability. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
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| Intervention ICMJE |
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| Publications * | Not Provided | ||||||||
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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 | ||||||||
| Estimated Enrollment ICMJE | 10000 | ||||||||
| Estimated Completion Date | August 2020 | ||||||||
| Estimated Primary Completion Date | August 2020 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 10 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01184638 | ||||||||
| Other Study ID Numbers ICMJE | NJMU-2010-07022, NJFY7M12 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | FuZhou Wang, Nanjing Medical University | ||||||||
| Study Sponsor ICMJE | Nanjing Medical University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Nanjing Medical University | ||||||||
| Verification Date | May 2011 | ||||||||
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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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