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The Incidence of Intra-Operative Awareness in China and Analysis of Relevant Factors: a Multicentre Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00693875
Recruitment Status : Completed
First Posted : June 9, 2008
Last Update Posted : January 28, 2009
Sponsor:
Collaborators:
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 and Gynecology Hospital
Beijing Hangtian General Hospital
Shanghai Rui Jin Hospital
Shanghai Zhongshan Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Guangzhou First People's Hospital
Nanfang Hospital of Southern Medical University
First Affiliated Hospital Xi'an Jiaotong University
Second Affiliated Hospital of Xi'an Jiaotong University
Xijing Hospital
Tang-Du Hospital
Xiangya Hospital of Central South University
Wuhan Union Hospital, China
Ningbo Medical Center Lihuili Hospital
First Hospital of China Medical University
First Hospital of Jilin University
Fuzhou General Hospital
Information provided by:
Capital Medical University

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.

Condition or disease
Intra-Operative Awareness

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 Type : Observational
Actual Enrollment : 11197 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Incidence of Intra-Operative Awareness in China and Analysis of Relevant Factors: a Multicentre Study
Study Start Date : April 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : June 2008



Primary Outcome Measures :
  1. evaluation of intra-operative awareness in all the patients investigated [ Time Frame: within 4 days after the general anesthesia ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693875


Locations
Show Show 25 study locations
Sponsors and Collaborators
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 and Gynecology Hospital
Beijing Hangtian General Hospital
Shanghai Rui Jin Hospital
Shanghai Zhongshan Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Guangzhou First People's Hospital
Nanfang Hospital of Southern Medical University
First Affiliated Hospital Xi'an Jiaotong University
Second Affiliated Hospital of Xi'an Jiaotong University
Xijing Hospital
Tang-Du Hospital
Xiangya Hospital of Central South University
Wuhan Union Hospital, China
Ningbo Medical Center Lihuili Hospital
First Hospital of China Medical University
First Hospital of Jilin University
Fuzhou General Hospital
Investigators
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Principal Investigator: Liang Xu, M.D. Capital Medical University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xu, Liang, BEIJING CHAOYANG HOSPITAL, CAPITAL MEDICAL UNIVERSITY
ClinicalTrials.gov Identifier: NCT00693875    
Other Study ID Numbers: CHAOYANG HOSPITAL
First Posted: June 9, 2008    Key Record Dates
Last Update Posted: January 28, 2009
Last Verified: January 2009
Keywords provided by Capital Medical University:
incidence
awareness
general anesthesia
relevant factor
the incidence of intra-operative awareness in China
the relevant factors
Additional relevant MeSH terms:
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Intraoperative Awareness
Intraoperative Complications
Pathologic Processes