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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00693875
Enrollment
11197
Registered
2008-06-09
Start date
2007-04-30
Completion date
2008-06-30
Last updated
2009-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intra-Operative Awareness

Keywords

incidence, awareness, general anesthesia, relevant factor, the incidence of intra-operative awareness in China, the relevant factors

Brief 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.

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
evaluation of intra-operative awareness in all the patients investigatedwithin 4 days after the general anesthesia

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026