The Incidence of Intra-Operative Awareness in China and Analysis of Relevant Factors: a Multicentre Study
- Conditions
- Intra-Operative Awareness
- Registration Number
- NCT00693875
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11197
- Patients received general anesthesia with tracheal intubation or LMA
- Apparently normal mental status
- Pediatric patients (<12 yr)
- Those who could not be interviewed in 24 hours after the operations
- Those unable to communicate in common spoken Chinese
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method evaluation of intra-operative awareness in all the patients investigated within 4 days after the general anesthesia
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Department of Anesthesiology, Guangzhou first people ' s hospital
🇨🇳Guangzhou, Guangdong, China
Department of Anesthesiology, China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Department of Anesthesiology, Beijing Friendship Hospital
🇨🇳Beijing, Beijing, China
Department of Anesthesiology, Fuzhou General Hospital
🇨🇳Fuzhou, Fujian, China
Department of Anesthesiology, Beijing Hangtian General Hospital
🇨🇳Beijing, Beijing, China
Department of Anesthesiology, Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Department of Anesthesiology, Beijing Command General Hospital
🇨🇳Beijing, Beijing, China
Department of Anesthesiology, Beijing Hospital
🇨🇳Beijing, Beijing, China
Department of Anesthesiology, Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China
Department of Anesthesiology, Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Department of Anesthesiology, the First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Department of Anesthesiology, Wuhan Union Hospital
🇨🇳Wuhan, Hubei, China
Department of Anesthesiology, Shanghai Zhongshan Hospital
🇨🇳Shanghai, Shanghai, China
Department of Anesthesiology, The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Department of Anesthesiology, Second Affiliated Hospital of Medical College of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Department of Anesthesiology, Xijing Hospital, FMMU
🇨🇳Xi'an, Shanxi, China
Department of Anesthesiology, Shanghai Rui Jin Hospital
🇨🇳Shanghai, Shanghai, China
Department of Anesthesioly,Peking University First Hospital
🇨🇳Beijing, Beijing, China
Department of Anesthesiology, Xuanwu Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
Department of Anesthesiology, Beijing Tongren Hospital
🇨🇳Beijing, Beijing, China
Departmet of Anesthesiology, Beijing Chao Yang Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Department of Anesthesiology, Shanghai Xinhua Hospital
🇨🇳Shanghai, Shanghai, China
Department of Anesthesiology, First Affiliated Hospital of Medical College of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Department of Anesthesiology, Beijing Obstetrics Gynecology Hospital
🇨🇳Beijing, Beijing, China
Department of Anesthesiology, Ningbo Lihuili Hospital
🇨🇳Ningbo, Zhejiang, China