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| 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 Gynecology Hospital Beijing Hangtian General Hospital Shanghai Rui Jin Hospital Shanghai Zhongshan Hospital Fuzhou General Hospital Guangzhou first people ' s hospital Nanfang Hospital First Affiliated Hospital of Medical College of Xi'an Jiaotong University 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 Shanghai Xinhua Hospital |
|---|---|
| Information provided by: | Capital Medical University |
| ClinicalTrials.gov Identifier: | NCT00693875 |
Purpose
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 |
|---|
|
Intra-Operative Awareness |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | The Incidence of Intra-Operative Awareness in China and Analysis of Relevant Factors: a Multicentre Study |
| Enrollment: | 11197 |
| Study Start Date: | April 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| China | |
| Department of Anesthesiology, Beijing Hospital | |
| Beijing, China, 100730 | |
| Department of Anesthesiology, China-Japan Friendship Hospital | |
| BEIJING, China, 100029 | |
| Department of Anesthesiology, Beijing Command General Hospital | |
| BEIJING, China, 100700 | |
| Department of Anesthesiology, Beijing Obstetrics Gynecology Hospital | |
| BEIJING, China, 100006 | |
| Department of Anesthesiology, Beijing Hangtian General Hospital | |
| BEIJING, China, 100076 | |
| Departmet of Anesthesiology, Beijing Chao Yang Hospital, Capital Medical University | |
| Beijing, China, 100020 | |
| Department of Anesthesiology, Shanghai Rui Jin Hospital | |
| SHANGHAI, China, 200025 | |
| Department of Anesthesiology, Peking University Third Hospital | |
| Beijing, China, 100083 | |
| Department of Anesthesiology, Beijing Friendship Hospital | |
| Beijing, China, 100050 | |
| Department of Anesthesiology, Beijing Tongren Hospital | |
| Beijing, China, 100730 | |
| Department of Anesthesiology, Xuanwu Hospital Capital Medical University | |
| Beijing, China, 100053 | |
| Department of Anesthesioly,Peking University First Hospital | |
| Beijing, China, 100034 | |
| Department of Anesthesiology, Shanghai Zhongshan Hospital | |
| SHANGHAI, China, 200032 | |
| Department of Anesthesiology, Shanghai Xinhua Hospital | |
| SHANGHAI, China, 200092 | |
| China, FUJIAN | |
| Department of Anesthesiology, Fuzhou General Hospital | |
| FUZHOU, FUJIAN, China, 354200 | |
| China, GUANGDONG | |
| Department of Anesthesiology, Nanfang Hospital | |
| GUANGZHOU, GUANGDONG, China, 510515 | |
| Department of Anesthesiology, Guangzhou first people ' s hospital | |
| GUANGZHOU, GUANGDONG, China, 510180 | |
| China, HUBEI | |
| Department of Anesthesiology, Wuhan Union Hospital | |
| WUHAN, HUBEI, China, 430022 | |
| China, HUNAN | |
| Department of Anesthesiology, Xiangya Hospital of Central South University | |
| CHANGSHA, HUNAN, China, 410078 | |
| China, JILIN | |
| Department of Anesthesiology, the First Hospital of Jilin University | |
| CHANGCHUN, JILIN, China, 130021 | |
| China, LIAONING | |
| Department of Anesthesiology, The First Hospital of China Medical University | |
| SHENYANG, LIAONING, China, 110001 | |
| China, SHANXI | |
| Department of Anesthesiology, First Affiliated Hospital of Medical College of Xi'an Jiaotong University | |
| XI'AN, SHANXI, China, 710061 | |
| Department of Anesthesiology, Second Affiliated Hospital of Medical College of Xi'an Jiaotong University | |
| XI'AN, SHANXI, China, 710000 | |
| Department of Anesthesiology, Xijing Hospital, FMMU | |
| XI'AN, SHANXI, China, 710032 | |
| China, ZHEJIANG | |
| Department of Anesthesiology, Ningbo Lihuili Hospital | |
| NINGBO, ZHEJIANG, China, 315040 | |
| Principal Investigator: | Liang Xu, M.D. | Capital Medical University |
More Information
| Responsible Party: | BEIJING CHAOYANG HOSPITAL, CAPITAL MEDICAL UNIVERSITY ( Xu, Liang ) |
| Study ID Numbers: | CHAOYANG HOSPITAL |
| Study First Received: | June 5, 2008 |
| Last Updated: | January 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00693875 History of Changes |
| Health Authority: | China: Ethics Committee |
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awareness general anesthesia incidence |
relevant factor the incidence of intra-operative awareness in China the relevant factors |
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Anesthetics |
