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The Incidence of Intra-Operative Awareness in China and Analysis of Relevant Factors: a Multicentre Study
This study has been completed.
Study NCT00693875   Information provided by Capital Medical University
First Received: June 5, 2008   Last Updated: January 27, 2009   History of Changes

June 5, 2008
January 27, 2009
April 2007
April 2008   (final data collection date for primary outcome measure)
evaluation of intra-operative awareness in all the patients investigated [ Time Frame: within 4 days after the general anesthesia ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00693875 on ClinicalTrials.gov Archive Site
 
 
 
The Incidence of Intra-Operative Awareness in China and Analysis of Relevant Factors: a Multicentre Study
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.

 
Observational
Cohort, Prospective
Intra-Operative Awareness
 
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
11197
June 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients received general anesthesia with tracheal intubation or LMA
  • Apparently normal mental status

Exclusion Criteria:

  • Pediatric patients (<12 yr)
  • Those who could not be interviewed in 24 hours after the operations
  • Those unable to communicate in common spoken Chinese
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00693875
Xu, Liang, BEIJING CHAOYANG HOSPITAL, CAPITAL MEDICAL UNIVERSITY
CHAOYANG HOSPITAL
Capital Medical University
  • Beijing Chao Yang Hospital
  • Peking University First Hospital
  • Peking University Third Hospital
  • Beijing Friendship Hospital
  • Beijing Tongren Hospital
  • Xuanwu Hospital, Beijing
  • Beijing Hospital
  • China-Japan Friendship Hospital
  • Beijing Command General Hospital
  • Beijing Obstetrics Gynecology Hospital
  • Beijing Hangtian General Hospital
  • Shanghai Rui Jin Hospital
  • Shanghai Zhongshan Hospital
  • Shanghai Xinhua Hospital
  • Guangzhou first people ' s hospital
  • Nanfang Hospital
  • Xi’an Jiaotong University College of Medicine
  • Second Affiliated Hospital of Medical College of Xi'an Jiaotong University
  • Xijing Hospital
  • Tang-Du Hospital
  • Xiangya Hospital of Central South University
  • Wuhan Union Hospital
  • Ningbo Lihuili Hospital
  • The First Hospital of China Medical University
  • the First Hospital of Jilin University
  • Fuzhou General Hospital
Principal Investigator: Liang Xu, M.D. Capital Medical University
Capital Medical University
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP