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NCT Number: NCT00693875

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology, Beijing Command General Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. evaluation of intra-operative awareness in all the patients investigated

    Time frame: within 4 days after the general anesthesia

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Collaborators

  • Beijing Chao Yang Hospital
  • Beijing Command General Hospital
  • Beijing Friendship Hospital
  • Beijing Hangtian General Hospital
  • Beijing Hospital
  • Beijing Obstetrics and Gynecology Hospital
  • Beijing Tongren Hospital
  • China-Japan Friendship Hospital
  • First Affiliated Hospital Xi'an Jiaotong University
  • First Hospital of China Medical University
  • Fuzhou General Hospital
  • Guangzhou First People's Hospital
  • Nanfang Hospital, Southern Medical University
  • Ningbo Medical Center Lihuili Hospital
  • Peking University First Hospital
  • Peking University Third Hospital
  • Second Affiliated Hospital of Xi'an Jiaotong University
  • Shanghai Rui Jin Hospital
  • Shanghai Zhongshan Hospital
  • Tang-Du Hospital
  • The First Hospital of Jilin University
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Xiangya Hospital of Central South University
  • Xijing Hospital
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  • Xuanwu Hospital, Beijing

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 9, 2008
Registry last updated
Jan 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.