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

Intra-Operative Awareness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693875
• Other study ID #: CHAOYANG HOSPITAL
• Status: Completed
• Phase: N/A
• First received: June 5, 2008
• Last updated: January 27, 2009
• Start date: April 2007
• Est. completion date: June 2008

Study information

• Verified date: January 2009
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11197
• Est. completion date: June 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intra-Operative Awareness
• Intraoperative Awareness

Locations

Country	Name	City	State
China	Department of Anesthesiology, Beijing Command General Hospital	Beijing	Beijing
China	Department of Anesthesiology, Beijing Friendship Hospital	Beijing	Beijing
China	Department of Anesthesiology, Beijing Hangtian General Hospital	Beijing	Beijing
China	Department of Anesthesiology, Beijing Hospital	Beijing	Beijing
China	Department of Anesthesiology, Beijing Obstetrics Gynecology Hospital	Beijing	Beijing
China	Department of Anesthesiology, Beijing Tongren Hospital	Beijing	Beijing
China	Department of Anesthesiology, China-Japan Friendship Hospital	Beijing	Beijing
China	Department of Anesthesiology, Peking University Third Hospital	Beijing	Beijing
China	Department of Anesthesiology, Xuanwu Hospital Capital Medical University	Beijing	Beijing
China	Department of Anesthesioly,Peking University First Hospital	Beijing	Beijing
China	Departmet of Anesthesiology, Beijing Chao Yang Hospital, Capital Medical University	Beijing	Beijing
China	Department of Anesthesiology, the First Hospital of Jilin University	Changchun	Jilin
China	Department of Anesthesiology, Xiangya Hospital of Central South University	Changsha	Hunan
China	Department of Anesthesiology, Fuzhou General Hospital	Fuzhou	Fujian
China	Department of Anesthesiology, Guangzhou first people ' s hospital	Guangzhou	Guangdong
China	Department of Anesthesiology, Nanfang Hospital	Guangzhou	Guangdong
China	Department of Anesthesiology, Ningbo Lihuili Hospital	Ningbo	Zhejiang
China	Department of Anesthesiology, Shanghai Rui Jin Hospital	Shanghai	Shanghai
China	Department of Anesthesiology, Shanghai Xinhua Hospital	Shanghai	Shanghai
China	Department of Anesthesiology, Shanghai Zhongshan Hospital	Shanghai	Shanghai
China	Department of Anesthesiology, The First Hospital of China Medical University	Shenyang	Liaoning
China	Department of Anesthesiology, Wuhan Union Hospital	Wuhan	Hubei
China	Department of Anesthesiology, First Affiliated Hospital of Medical College of Xi'an Jiaotong University	Xi'an	Shanxi
China	Department of Anesthesiology, Second Affiliated Hospital of Medical College of Xi'an Jiaotong University	Xi'an	Shanxi
China	Department of Anesthesiology, Xijing Hospital, FMMU	Xi'an	Shanxi

Sponsors (27)

Lead Sponsor

Collaborator

Capital Medical University

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, First Hospital of Jilin University, Fuzhou General Hospital, Guangzhou First Municipal People’s Hospital, Nanfang Hospital of Southern Medical University, Ningbo 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, Wuhan Union Hospital, China, Xiangya Hospital of Central South University, Xijing Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of intra-operative awareness in all the patients investigated		within 4 days after the general anesthesia	No