An observational study in Intra-Operative Awareness, sponsored by Capital Medical University. Completed at 25 sites in China. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2009-01-28.
Sponsored by Capital Medical University · Observational
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.
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.
51 studies on the registry are indexed under Intraoperative Awareness; 7 are open to participants now.
This study's enrollment of 11,197 is above the median of 108 across 26 observational studies indexed under Intraoperative Awareness.
Browse Intraoperative Awareness studies →Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.
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The subjects would be selected from the patients of the 24 hospitals who would undergo general anesthesia during different kinds of operations in different areas around China after the written informed consents obtained. Each hospital would continuously provide 500～600 subjects for the investigation.
Exclusion Criteria:
evaluation of intra-operative awareness in all the patients investigated
Time frame: within 4 days after the general anesthesia
This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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Capital Medical University