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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 5, 2008 | ||||
| Last Updated Date | January 27, 2009 | ||||
| Start Date ICMJE | April 2007 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
evaluation of intra-operative awareness in all the patients investigated [ Time Frame: within 4 days after the general anesthesia ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00693875 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Incidence of Intra-Operative Awareness in China and Analysis of Relevant Factors: a Multicentre Study | ||||
| Official Title ICMJE | The Incidence of Intra-Operative Awareness in China and Analysis of Relevant Factors: a Multicentre Study | ||||
| Brief Summary | Medical literature about awareness during general anesthesia is rare in China, and some small sampled studies in China showed a significantly higher incidence (1.5~6%) of intra-operative awareness compared with western countries. The investigators sponsored this multicenter, large sampled, prospective study to determine the incidence of intra-operative awareness in China, and the preservation effect of BIS monitor on the incidence of awareness. |
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| Detailed Description | Background: The incidence of awareness in patients undergoing general anesthesia has been reported in as many as 0.1~0.2% in western countries. But so far,medical literature about awareness during general anesthesia is still rare in China, and some small sampled studies in China showed a significantly higher incidence (1.5~6%) of intra-operative awareness. We believed that this multicenter, large sampled, prospective study would be very necessary for us to determine the incidence of intra-operative awareness in China, and analysis of the relevant factors would help us to understand why was the incidence of awareness in China much higher than that in western countries. Methods: This is a prospective, nonrandomized descriptive cohort study that was conducted at 25 academic medical centers in China. 11,197 patients (age>12, intubation or LMA during anesthesia) form 25 medical centers were enrolled to be interviewed by research stuff for evaluation of awareness at the 1st and 4th day after their general anesthesia. The structured interview questions were:⑴What is the last thing you remembered before you went to sleep? ⑵What is the first thing you remembered when you woke up? ⑶Can you remember anything between these two periods? ⑷Did you dream during your operation? ⑸What was the worst thing about your operation? An evaluation committee independent from the research stuff was constituted to verify the data from the medical centers. And then the incidence of intra-operative awareness in China was determined. General condition and details of the anesthesia procedure of the patients were also recorded during the anesthesia for a binary logistic regression analysis. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Cohort, Prospective | ||||
| Condition ICMJE | Intra-Operative Awareness | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | Xu L, Wu AS, Yue Y. The incidence of intra-operative awareness during general anesthesia in China: a multi-center observational study. Acta Anaesthesiol Scand. 2009 Aug;53(7):873-82. Epub 2009 Jun 3. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 11197 | ||||
| Completion Date | June 2008 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00693875 | ||||
| Responsible Party | Xu, Liang, BEIJING CHAOYANG HOSPITAL, CAPITAL MEDICAL UNIVERSITY | ||||
| Study ID Numbers ICMJE | CHAOYANG HOSPITAL | ||||
| Study Sponsor ICMJE | Capital Medical University | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Capital Medical University | ||||
| Verification Date | January 2009 | ||||
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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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