Clinical trial NCT00693875: The Incidence of Intra-Operative Awareness in China and Analysis of Relevant Factors: a Multicentre Study
Official title: The Incidence of Intra-Operative Awareness in China and Analysis of Relevant Factors: a Multicentre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intra-Operative Awareness
Keywords: incidence
awareness
general anesthesia
relevant factor
the incidence of intra-operative awareness in China
the relevant factors
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Chao Yang Hospital
name: Peking University First Hospital
name: Peking University Third Hospital
name: Beijing Friendship Hospital
name: Beijing Tongren Hospital
name: Xuanwu Hospital, Beijing
name: Beijing Hospital
name: China-Japan Friendship Hospital
name: Beijing Command General Hospital
name: Beijing Obstetrics and Gynecology Hospital
name: Beijing Hangtian General Hospital
name: Shanghai Rui Jin Hospital
name: Shanghai Zhongshan Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Guangzhou First People's Hospital
name: Nanfang Hospital, Southern Medical University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Second Affiliated Hospital of Xi'an Jiaotong University
name: Xijing Hospital
name: Tang-Du Hospital
name: Xiangya Hospital of Central South University
name: Wuhan Union Hospital, China
name: Ningbo Medical Center Lihuili Hospital
name: First Hospital of China Medical University
name: The First Hospital of Jilin University
name: Fuzhou General Hospital
First posted: 2008-06-09
Enrollment: 11197
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: evaluation of intra-operative awareness in all the patients investigated
timeFrame: within 4 days after the general anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Anesthesiology, Beijing Obstetrics Gynecology Hospital
state: Beijing
city: Beijing
country: China
facility: Departmet of Anesthesiology, Beijing Chao Yang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Department of Anesthesiology, China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Department of Anesthesioly,Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Department of Anesthesiology, Beijing Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Department of Anesthesiology, Xuanwu Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Department of Anesthesiology, Beijing Hangtian General Hospital
state: Beijing
city: Beijing
country: China
facility: Department of Anesthesiology, Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Department of Anesthesiology, Beijing Command General Hospital
state: Beijing
city: Beijing
country: China
facility: Department of Anesthesiology, Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Department of Anesthesiology, Beijing Tongren Hospital
state: Beijing
city: Fuzhou
country: China
facility: Department of Anesthesiology, Fuzhou General Hospital
state: Fujian
city: Guangzhou
country: China
facility: Department of Anesthesiology, Guangzhou first people ' s hospital
state: Guangdong
city: Guangzhou
country: China
facility: Department of Anesthesiology, Nanfang Hospital
state: Guangdong
city: Wuhan
country: China
facility: Department of Anesthesiology, Wuhan Union Hospital
state: Hubei
city: Changsha
country: China
facility: Department of Anesthesiology, Xiangya Hospital of Central South University
state: Hunan
city: Changchun
country: China
facility: Department of Anesthesiology, the First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Department of Anesthesiology, The First Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Department of Anesthesiology, Shanghai Rui Jin Hospital
state: Shanghai
city: Shanghai
country: China
facility: Department of Anesthesiology, Shanghai Zhongshan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Department of Anesthesiology, Shanghai Xinhua Hospital
state: Shanghai
city: Xi'an
country: China
facility: Department of Anesthesiology, Second Affiliated Hospital of Medical College of Xi'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: Department of Anesthesiology, Xijing Hospital, FMMU
state: Shanxi
city: Xi'an
country: China
facility: Department of Anesthesiology, First Affiliated Hospital of Medical College of Xi'an Jiaotong University
state: Shanxi
city: Ningbo
country: China
facility: Department of Anesthesiology, Ningbo Lihuili Hospital
state: Zhejiang
Study officials:
affiliation: Capital Medical University
name: Liang Xu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.