Intra-Operative AwarenessNCT00693875
The Incidence of Intra-Operative Awareness in China and Analysis of Relevant Factors: a Multicentre Study
An observational study of Intra-Operative Awareness, run by Capital Medical University at 25 sites in China.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Intra-Operative Awareness
- How many people
- 11,197 participants
- Where
- 25 sitesChina
- Study dates
- Apr 2007to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients received general anesthesia with tracheal intubation or LMA
- Apparently normal mental status
Who cannot join
- Pediatric patients (<12 yr)
- Those who could not be interviewed in 24 hours after the operations
- Those unable to communicate in common spoken Chinese
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
Department of Anesthesiology, Beijing Obstetrics Gynecology Hospital
Beijing, Beijing Municipality, 100006
Departmet of Anesthesiology, Beijing Chao Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
Department of Anesthesiology, China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Department of Anesthesioly,Peking University First Hospital
Beijing, Beijing Municipality, 100034
Department of Anesthesiology, Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Department of Anesthesiology, Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Department of Anesthesiology, Beijing Hangtian General Hospital
Beijing, Beijing Municipality, 100076
Department of Anesthesiology, Peking University Third Hospital
Beijing, Beijing Municipality, 100083
Department of Anesthesiology, Beijing Command General Hospital
Beijing, Beijing Municipality, 100700
Department of Anesthesiology, Beijing Hospital
Beijing, Beijing Municipality, 100730
Department of Anesthesiology, Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730
Department of Anesthesiology, the First Hospital of Jilin University
Changchun, Jilin, 130021
Department of Anesthesiology, Xiangya Hospital of Central South University
Changsha, Hunan, 410078
Department of Anesthesiology, Fuzhou General Hospital
Fuzhou, Fujian, 354200
Department of Anesthesiology, Guangzhou first people ' s hospital
Guangzhou, Guangdong, 510180
Department of Anesthesiology, Nanfang Hospital
Guangzhou, Guangdong, 510515
Department of Anesthesiology, Ningbo Lihuili Hospital
Ningbo, Zhejiang, 315040
Department of Anesthesiology, Shanghai Rui Jin Hospital
Shanghai, Shanghai Municipality, 200025
Department of Anesthesiology, Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Department of Anesthesiology, Shanghai Xinhua Hospital
Shanghai, Shanghai Municipality, 200092
Department of Anesthesiology, The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Department of Anesthesiology, Wuhan Union Hospital
Wuhan, Hubei, 430022
Department of Anesthesiology, Second Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi’an, Shanxi, 710000
Department of Anesthesiology, Xijing Hospital, FMMU
Xi’an, Shanxi, 710032
Department of Anesthesiology, First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
About this 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.
Read the 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.
- Conditions
- Intra-Operative Awareness
- Keywords
- incidence, awareness, general anesthesia, relevant factor, the incidence of intra-operative awareness in China, the relevant factors
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of intra-operative awareness in all the patients investigated
Measured: within 4 days after the general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startApr 2007
- Primary completionApr 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intra-Operative AwarenessStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11,197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- 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 People's Hospital, Nanfang Hospital, Southern Medical University, First Affiliated Hospital Xi'an Jiaotong University, Second Affiliated Hospital of Xi'an Jiaotong University, Xijing Hospital, Tang-Du Hospital, Xiangya Hospital of Central South University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Ningbo Medical Center Lihuili Hospital, First Hospital of China Medical University, The First Hospital of Jilin University, Fuzhou General Hospital
- Investigators
- Liang Xu, M.D., Principal investigator, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693875
- Sponsor's protocol ID
- CHAOYANG HOSPITAL
- Status last verified
- Jan 2009
- First submitted
- 5 Jun 2008
- Last updated
- 28 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xu L, Wu AS, Yue Y. The incidence of intra-operative awareness during general anesthesia in China: a multi-center observational study. Acta Anaesthesiol Scand. 2009 Aug;53(7):873-82. doi: 10.1111/j.1399-6576.2009.02016.x. Epub 2009 Jun 3.
PubMed 19496761
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Intra-Operative Awareness in China and Analysis of Relevant Factors: a Multicentre Study
- ClinicalTrials.gov ID
- NCT00693875
- Acronym / sponsor ID
- CHAOYANG HOSPITAL
- Conditions
- Intra-Operative Awareness
- Keywords
- incidence, awareness, general anesthesia, relevant factor, the incidence of intra-operative awareness in China, the relevant factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,197 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- 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 People's Hospital, Nanfang Hospital, Southern Medical University, First Affiliated Hospital Xi'an Jiaotong University, Second Affiliated Hospital of Xi'an Jiaotong University, Xijing Hospital, Tang-Du Hospital, Xiangya Hospital of Central South University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Ningbo Medical Center Lihuili Hospital, First Hospital of China Medical University, The First Hospital of Jilin University, Fuzhou General Hospital
- Study start
- Apr 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 9 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients received general anesthesia with tracheal intubation or LMA
- Apparently normal mental status
Key exclusion criteria (3 listed)
- Pediatric patients (<12 yr)
- Those who could not be interviewed in 24 hours after the operations
- Those unable to communicate in common spoken Chinese
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluation of intra-operative awareness in all the patients investigated
Time frame: within 4 days after the general anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2009.
- Derived from this study: PubMed 19496761Xu L, Wu AS, Yue Y. The incidence of intra-operative awareness during general anesthesia in China: a multi-center observational study. Acta Anaesthesiol Scand. 2009 Aug;53(7):873-82. doi: 10.1111/j.1399-6576.2009.02016.x. Epub 2009 Jun 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liang Xu, M.D. principal investigator
Capital Medical University
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intra-Operative Awareness, run by Capital Medical University at 25 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of intra-operative awareness in all the patients investigated (time frame: within 4 days after the general anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00693875, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2009.