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

This study has been completed.
Sponsor:
Collaborators:
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 and Gynecology Hospital
Beijing Hangtian General Hospital
Shanghai Rui Jin Hospital
Shanghai Zhongshan Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Guangzhou First Municipal People’s Hospital
Nanfang Hospital of Southern Medical University
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, China
Ningbo Lihuili Hospital
China Medical University, China
First Hospital of Jilin University
Fuzhou General Hospital
Information provided by:
Capital Medical University
ClinicalTrials.gov Identifier:
NCT00693875
First received: June 5, 2008
Last updated: January 27, 2009
Last verified: January 2009
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Incidence of Intra-Operative Awareness in China and Analysis of Relevant Factors: a Multicentre Study

Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • evaluation of intra-operative awareness in all the patients investigated [ Time Frame: within 4 days after the general anesthesia ] [ Designated as safety issue: No ]

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)
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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693875

Locations
China, Beijing
Department of Anesthesiology, Beijing Hospital
Beijing, Beijing, China, 100730
Department of Anesthesiology, China-Japan Friendship Hospital
Beijing, Beijing, China, 100029
Department of Anesthesiology, Beijing Command General Hospital
Beijing, Beijing, China, 100700
Department of Anesthesiology, Beijing Obstetrics Gynecology Hospital
Beijing, Beijing, China, 100006
Department of Anesthesiology, Beijing Hangtian General Hospital
Beijing, Beijing, China, 100076
Departmet of Anesthesiology, Beijing Chao Yang Hospital, Capital Medical University
Beijing, Beijing, China, 100020
Department of Anesthesioly,Peking University First Hospital
Beijing, Beijing, China, 100034
Department of Anesthesiology, Peking University Third Hospital
Beijing, Beijing, China, 100083
Department of Anesthesiology, Beijing Friendship Hospital
Beijing, Beijing, China, 100050
Department of Anesthesiology, Beijing Tongren Hospital
Beijing, Beijing, China, 100730
Department of Anesthesiology, Xuanwu Hospital Capital Medical University
Beijing, Beijing, China, 100053
China, Fujian
Department of Anesthesiology, Fuzhou General Hospital
Fuzhou, Fujian, China, 354200
China, Guangdong
Department of Anesthesiology, Guangzhou first people ' s hospital
Guangzhou, Guangdong, China, 510180
Department of Anesthesiology, Nanfang Hospital
Guangzhou, Guangdong, China, 510515
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, Shanghai
Department of Anesthesiology, Shanghai Rui Jin Hospital
Shanghai, Shanghai, China, 200025
Department of Anesthesiology, Shanghai Zhongshan Hospital
Shanghai, Shanghai, China, 200032
Department of Anesthesiology, Shanghai Xinhua Hospital
Shanghai, Shanghai, China, 200092
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
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 and Gynecology Hospital
Beijing Hangtian General Hospital
Shanghai Rui Jin Hospital
Shanghai Zhongshan Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Guangzhou First Municipal People’s Hospital
Nanfang Hospital of Southern Medical University
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, China
Ningbo Lihuili Hospital
China Medical University, China
First Hospital of Jilin University
Fuzhou General Hospital
Investigators
Principal Investigator: Liang Xu, M.D. Capital Medical University
  More Information

No publications provided by Capital Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xu, Liang, BEIJING CHAOYANG HOSPITAL, CAPITAL MEDICAL UNIVERSITY
ClinicalTrials.gov Identifier: NCT00693875     History of Changes
Other Study ID Numbers: CHAOYANG HOSPITAL
Study First Received: June 5, 2008
Last Updated: January 27, 2009
Health Authority: China: Ethics Committee

Keywords provided by Capital Medical University:
incidence
awareness
general anesthesia
relevant factor
the incidence of intra-operative awareness in China
the relevant factors

Additional relevant MeSH terms:
Intraoperative Awareness
Intraoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014