The Incidence of Intra-Operative Awareness in China and Analysis of Relevant Factors: a Multicentre Study
1 other identifier
observational
11,197
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2007
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 5, 2008
CompletedFirst Posted
Study publicly available on registry
June 9, 2008
CompletedJanuary 28, 2009
January 1, 2009
1 year
June 5, 2008
January 27, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
evaluation of intra-operative awareness in all the patients investigated
within 4 days after the general anesthesia
Eligibility Criteria
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.
You may qualify if:
- Patients received general anesthesia with tracheal intubation or LMA
- Apparently normal mental status
You may not qualify if:
- Pediatric patients (\<12 yr)
- Those who could not be interviewed in 24 hours after the operations
- Those unable to communicate in common spoken Chinese
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Capital Medical Universitylead
- Beijing Chao Yang Hospitalcollaborator
- Peking University First Hospitalcollaborator
- Peking University Third Hospitalcollaborator
- Beijing Friendship Hospitalcollaborator
- Beijing Tongren Hospitalcollaborator
- Xuanwu Hospital, Beijingcollaborator
- Beijing Hospitalcollaborator
- China-Japan Friendship Hospitalcollaborator
- Beijing Command General Hospitalcollaborator
- Beijing Obstetrics and Gynecology Hospitalcollaborator
- Beijing Hangtian General Hospitalcollaborator
- Shanghai Rui Jin Hospitalcollaborator
- Shanghai Zhongshan Hospitalcollaborator
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicinecollaborator
- Guangzhou First People's Hospitalcollaborator
- Nanfang Hospital, Southern Medical Universitycollaborator
- First Affiliated Hospital Xi'an Jiaotong Universitycollaborator
- Second Affiliated Hospital of Xi'an Jiaotong Universitycollaborator
- Xijing Hospitalcollaborator
- Tang-Du Hospitalcollaborator
- Xiangya Hospital of Central South Universitycollaborator
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technologycollaborator
- Ningbo Medical Center Lihuili Hospitalcollaborator
- First Hospital of China Medical Universitycollaborator
- The First Hospital of Jilin Universitycollaborator
- Fuzhou General Hospitalcollaborator
Study Sites (25)
Department of Anesthesiology, Beijing Obstetrics Gynecology Hospital
Beijing, Beijing Municipality, 100006, China
Departmet of Anesthesiology, Beijing Chao Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020, China
Department of Anesthesiology, China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Department of Anesthesioly,Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Department of Anesthesiology, Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050, China
Department of Anesthesiology, Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053, China
Department of Anesthesiology, Beijing Hangtian General Hospital
Beijing, Beijing Municipality, 100076, China
Department of Anesthesiology, Peking University Third Hospital
Beijing, Beijing Municipality, 100083, China
Department of Anesthesiology, Beijing Command General Hospital
Beijing, Beijing Municipality, 100700, China
Department of Anesthesiology, Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Department of Anesthesiology, Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730, China
Department of Anesthesiology, Fuzhou General Hospital
Fuzhou, Fujian, 354200, China
Department of Anesthesiology, Guangzhou first people ' s hospital
Guangzhou, Guangdong, 510180, China
Department of Anesthesiology, Nanfang Hospital
Guangzhou, Guangdong, 510515, China
Department of Anesthesiology, Wuhan Union Hospital
Wuhan, Hubei, 430022, China
Department of Anesthesiology, Xiangya Hospital of Central South University
Changsha, Hunan, 410078, China
Department of Anesthesiology, the First Hospital of Jilin University
Changchun, Jilin, 130021, China
Department of Anesthesiology, The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Department of Anesthesiology, Shanghai Rui Jin Hospital
Shanghai, Shanghai Municipality, 200025, China
Department of Anesthesiology, Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
Department of Anesthesiology, Shanghai Xinhua Hospital
Shanghai, Shanghai Municipality, 200092, China
Department of Anesthesiology, Second Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi’an, Shanxi, 710000, China
Department of Anesthesiology, Xijing Hospital, FMMU
Xi’an, Shanxi, 710032, China
Department of Anesthesiology, First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
Department of Anesthesiology, Ningbo Lihuili Hospital
Ningbo, Zhejiang, 315040, China
Related Publications (1)
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. doi: 10.1111/j.1399-6576.2009.02016.x. Epub 2009 Jun 3.
PMID: 19496761DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Liang Xu, M.D.
Capital Medical University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 5, 2008
First Posted
June 9, 2008
Study Start
April 1, 2007
Primary Completion
April 1, 2008
Study Completion
June 1, 2008
Last Updated
January 28, 2009
Record last verified: 2009-01