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

Information source: Capital Medical University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Intra-Operative Awareness

Phase: N/A

Status: Recruiting

Sponsored by: Capital Medical University

Official(s) and/or principal investigator(s):
Liang Xu, M.D., Principal Investigator, Affiliation: Capital Medical University

Overall contact:
Liang Xu, M.D., Phone: +8613810317299, Email: leonnel@msn.com

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. We 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.

Clinical Details

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

Study design: Cohort, Prospective

Primary outcome: evaluation of intra-operative awareness in all the patients investigated

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

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Liang Xu, M.D., Phone: +8613810317299, Email: leonnel@msn.com

Department of Anesthesiology, Beijing Hospital, Beijing 100730, China; Completed

Department of Anesthesiology, China-Japan Friendship Hospital, BEIJING 100029, China; Completed

Department of Anesthesiology, Beijing Command General Hospital, BEIJING 100700, China; Completed

Department of Anesthesiology, Beijing Obstetrics Gynecology Hospital, BEIJING 100006, China; Completed

Department of Anesthesiology, Beijing Hangtian General Hospital, BEIJING 100076, China; Completed

Departmet of Anesthesiology, Beijing Chao Yang Hospital, Capital Medical University, Beijing 100020, China; Recruiting
Liang Xu, M.D., Phone: +8613810317299, Email: leonnel@msn.com
Yun Yue, M.D., Phone: +861085231463, Email: yueyun@hotmail.com

Department of Anesthesioly,Peking University First Hospital, Beijing 100034, China; Completed

Department of Anesthesiology, Peking University Third Hospital, Beijing 100083, China; Completed

Department of Anesthesiology, Beijing Friendship Hospital, Beijing 100050, China; Completed

Department of Anesthesiology, Beijing Tongren Hospital, Beijing 100730, China; Completed

Department of Anesthesiology, Xuanwu Hospital Capital Medical University, Beijing 100053, China; Completed

Department of Anesthesiology, Shanghai Rui Jin Hospital, SHANGHAI 200025, China; Completed

Department of Anesthesiology, Shanghai Zhongshan Hospital, SHANGHAI 200032, China; Completed

Department of Anesthesiology, Shanghai Xinhua Hospital, SHANGHAI 200092, China; Completed

Department of Anesthesiology, Fuzhou General Hospital, FUZHOU, FUJIAN 354200, China; Completed

Department of Anesthesiology, Guangzhou first people ' s hospital, GUANGZHOU, GUANGDONG 510180, China; Completed

Department of Anesthesiology, Nanfang Hospital, GUANGZHOU, GUANGDONG 510515, China; Completed

Department of Anesthesiology, Wuhan Union Hospital, WUHAN, HUBEI 430022, China; Completed

Department of Anesthesiology, Xiangya Hospital of Central South University, CHANGSHA, HUNAN 410078, China; Completed

Department of Anesthesiology, the First Hospital of Jilin University, CHANGCHUN, JILIN 130021, China; Completed

Department of Anesthesiology, The First Hospital of China Medical University, SHENYANG, LIAONING 110001, China; Completed

Department of Anesthesiology, First Affiliated Hospital of Medical College of Xi'an Jiaotong University, XI'AN, SHANXI 710061, China; Completed

Department of Anesthesiology, Second Affiliated Hospital of Medical College of Xi'an Jiaotong University, XI'AN, SHANXI 710000, China; Completed

Department of Anesthesiology, Xijing Hospital, FMMU, XI'AN, SHANXI 710032, China; Completed

Department of Anesthesiology, Ningbo Lihuili Hospital, NINGBO, ZHEJIANG 315040, China; Completed

Additional Information

Starting date: April 2007
Ending date: June 2008
Last updated: June 6, 2008

Page last updated: November 03, 2008

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