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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 11197

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100006
      • Department of Anesthesiology, Beijing Obstetrics Gynecology Hospital
    • Beijing, Beijing, China, 100020
      • Departmet of Anesthesiology, Beijing Chao Yang Hospital, Capital Medical University
    • Beijing, Beijing, China, 100029
      • Department of Anesthesiology, China-Japan Friendship Hospital
    • Beijing, Beijing, China, 100034
      • Department of Anesthesioly,Peking University First Hospital
    • Beijing, Beijing, China, 100050
      • Department of Anesthesiology, Beijing Friendship Hospital
    • Beijing, Beijing, China, 100053
      • Department of Anesthesiology, Xuanwu Hospital Capital Medical University
    • Beijing, Beijing, China, 100076
      • Department of Anesthesiology, Beijing Hangtian General Hospital
    • Beijing, Beijing, China, 100083
      • Department of Anesthesiology, Peking University Third Hospital
    • Beijing, Beijing, China, 100700
      • Department of Anesthesiology, Beijing Command General Hospital
    • Beijing, Beijing, China, 100730
      • Department of Anesthesiology, Beijing Hospital
    • Beijing, Beijing, China, 100730
      • Department of Anesthesiology, Beijing Tongren Hospital
  • Fujian
    • Fuzhou, Fujian, China, 354200
      • Department of Anesthesiology, Fuzhou General Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510180
      • Department of Anesthesiology, Guangzhou first people ' s hospital
    • Guangzhou, Guangdong, China, 510515
      • Department of Anesthesiology, Nanfang Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Department of Anesthesiology, Wuhan Union Hospital
  • Hunan
    • Changsha, Hunan, China, 410078
      • Department of Anesthesiology, Xiangya Hospital of Central South University
  • Jilin
    • Changchun, Jilin, China, 130021
      • Department of Anesthesiology, the First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • Department of Anesthesiology, the First Hospital of China Medical University
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Department of Anesthesiology, Shanghai Rui Jin Hospital
    • Shanghai, Shanghai, China, 200032
      • Department of Anesthesiology, Shanghai Zhongshan Hospital
    • Shanghai, Shanghai, China, 200092
      • Department of Anesthesiology, Shanghai Xinhua Hospital
  • Shanxi
    • Xi'an, Shanxi, China, 710000
      • Department of Anesthesiology, Second Affiliated Hospital of Medical College of Xi'an Jiaotong University
    • Xi'an, Shanxi, China, 710032
      • Department of Anesthesiology, Xijing Hospital, FMMU
    • Xi'an, Shanxi, China, 710061
      • Department of Anesthesiology, First Affiliated Hospital of Medical College of Xi'an Jiaotong University
  • Zhejiang
    • Ningbo, Zhejiang, China, 315040
      • Department of Anesthesiology, Ningbo Lihuili Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
evaluation of intra-operative awareness in all the patients investigated	within 4 days after the general anesthesia

Collaborators and Investigators

• Sponsor: Capital Medical University
• Collaborators: Peking University First Hospital; Xijing Hospital; Xiangya Hospital of Central South University; Beijing Friendship Hospital; Shanghai Zhongshan Hospital; Peking University Third Hospital; Guangzhou First People's Hospital; First Affiliated Hospital Xi'an Jiaotong University; Nanfang Hospital of Southern Medical University; Xuanwu Hospital, Beijing; Ningbo Medical Center Lihuili Hospital; Beijing Tongren Hospital; Beijing Chao Yang Hospital; Beijing Hospital; China-Japan Friendship Hospital; The First Hospital of Jilin University; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Wuhan Union Hospital, China; Second Affiliated Hospital of Xi'an Jiaotong University; Tang-Du Hospital; First Hospital of China Medical University; Fuzhou General Hospital; Beijing Obstetrics and Gynecology Hospital; Beijing Command General Hospital; Beijing Hangtian General Hospital; Shanghai Rui Jin Hospital
• Investigators: Principal Investigator: Liang Xu, M.D., Capital Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: June 5, 2008
• First Submitted That Met QC Criteria: June 6, 2008
• First Posted (Estimate): June 9, 2008

Study Record Updates

• Last Update Posted (Estimate): January 28, 2009
• Last Update Submitted That Met QC Criteria: January 27, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: general anesthesia; incidence; awareness; relevant factor; the incidence of intra-operative awareness in China; the relevant factors
• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Intraoperative Awareness
• Other Study ID Numbers: CHAOYANG HOSPITAL