Intra-Operative Awareness Clinical Trial
Official title:
The Incidence of Intra-Operative Awareness in China and Analysis of Relevant Factors: a Multicentre Study
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.
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Observational Model: Cohort, Time Perspective: Prospective