Anesthesia, GeneralNCT01199471

Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane

An observational study of Anesthesia, General, run by Abbott at 40 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Anesthesia, General
How many people: 4,000 participants
Where: 40 sitesChina
Study dates: Sep 2010to Nov 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Chinese patients undergoing surgery requiring general anesthesia with endotracheal intubation or laryngeal mask airway

Who may be able to join

ASA (American Society of Anesthesiologists) physical status (a requirement of the patient's physical status): I to III
Age from 18 to 70 years
Surgery requiring general anesthesia with endotracheal intubation or laryngeal mask airway.

Who cannot join

History of significant cardiovascular, pulmonary, renal, hepatic or central nervous system disease or muscle disease.
Hypersensitivity or unusual response to any halogenated anesthetics.
Personal or familial history of malignant hyperthermia.
Female patients either pregnant or breast feeding.
General anesthesia is administered with total intravenous anesthesia (TIVA) of propofol.

Trial locations and contacts

40 sites in 1 country.

City, postcode or hospital

40 sites in 1 country

China40 sites

Site Reference ID/Investigator# 43056
Beijing, 100029
Site Reference ID/Investigator# 43060
Beijing, 100035
Site Reference ID/Investigator# 46406
Beijing, 100039
Site Reference ID/Investigator# 43058
Beijing, 100044
Site Reference ID/Investigator# 44382
Beijing, 100050
Site Reference ID/Investigator# 43059
Beijing, 100081
Site Reference ID/Investigator# 43062
Beijing, 100191
Site Reference ID/Investigator# 43063
Beijing, 100700
Site Reference ID/Investigator# 43061
Beijing, 100730
Site Reference ID/Investigator# 43057
Beining, 100037
Site Reference ID/Investigator# 43065
Chengdu, Sichuan, 610072
Site Reference ID/Investigator# 43064
Chengdu, Sichuan, 610083
Site Reference ID/Investigator# 44384
Daqing, 163316
Site Reference ID/Investigator# 43073
Guangzhou, Guangdong, 510120
Site Reference ID/Investigator# 43072
Guangzhou, Guangdong, 510150
Site Reference ID/Investigator# 46407
Guangzhou, Guangdong, 510220
Site Reference ID/Investigator# 43076
Guangzhou, Guangdong, 510515
Site Reference ID/Investigator# 43077
Guangzhou, Guangdong, 528000
Site Reference ID/Investigator# 44383
Guangzhou, 510260
Site Reference ID/Investigator# 43074
Guangzhou, 510630
Site Reference ID/Investigator# 43066
Harbin, Heilongjiang, 150001
Site Reference ID/Investigator# 43068
Harbin, Heilongjiang, 150001
Site Reference ID/Investigator# 43067
Harbin, 150040
Site Reference ID/Investigator# 43051
Jiangsu, 210002
Site Reference ID/Investigator# 43015
Shanghai, 200003
Site Reference ID/Investigator# 43017
Shanghai, 200011
Site Reference ID/Investigator# 41554
Shanghai, 200025
Site Reference ID/Investigator# 46405
Shanghai, 200040
Site Reference ID/Investigator# 43012
Shanghai, 200080
Site Reference ID/Investigator# 43014
Shanghai, 200092
Site Reference ID/Investigator# 43011
Shanghai, 200127
Site Reference ID/Investigator# 43018
Shanghai, 200433
Site Reference ID/Investigator# 46404
Shanghai, 200438
Site Reference ID/Investigator# 43071
Wuhan, Hubei, 430060
Site Reference ID/Investigator# 43070
Wuhan, Hubei
Site Reference ID/Investigator# 43069
Wuhan, Hubei, 430022
Site Reference ID/Investigator# 43052
Zhejiang, 310003
Site Reference ID/Investigator# 43053
Zhejiang, 310009
Site Reference ID/Investigator# 43054
Zhejiang, 310016
Site Reference ID/Investigator# 43055
Zhejiang, 310022

Other trials in China

About this study

Official title: A Multi-center Registry to Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane

This registry is primarily aiming to demonstrate the correlation between good practices of anesthesiologists and patient related outcomes including decreased overall anesthesia cost. The investigators would also like to demonstrate how the training background, and experience in inhalational anesthesia of the anesthesiologist influence their daily practice. At the end of the registry, the investigators would be able to demonstrate the influence of different practice pattern on patient related outcomes between the sites at which anesthesiologists follow modern anesthesiology practice based on their training/experience background and at which anesthesiologists do not follow same type of practice due to lack of their inhalational anesthesia training/experience.

Conditions: Anesthesia, General
Keywords: Sevoflurane, Physician's Practice Patterns, Economics, Pharmaceutical, Chinese

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01199471
Study group	Role	What they receive
Chinese Patients Requiring Surgery with Anesthesia		Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia (sevoflurane) administered per local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA).

What is being measured

The primary outcome is the main question the study is designed to answer.

Anesthesiologist Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)
Anesthesiologist satisfaction with the anesthesia administered to each patient during surgery was recorded at the end of the operation using a Numeric Analog Scale (NAS) from 0 (not satisfied at all) to 10 (completely satisfied) are summarized.
Measured: Within 24 hours
Patient Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)
Patient satisfaction with the anesthesia recorded at the end of the operation within 24 hours using a numeric analog scale (NAS) from 0 (not satisfied at all) to 10 (completely satisfied) are summarized.
Measured: Within 24 hours

Secondary outcomes (4)

Time to Loss of Consciousness of Patients Administered Anesthesia
The time to loss of consciousness was measured from commencement of administration of anesthesia to the patient's loss of consciousness (no response to command).
Measured: Up to 10 minutes
Time to Intubation of Patients
The time to intubation of the patients was measured from the commencement of administration of anesthesia to intubation of each patient.
Measured: Up to 10 minutes
Time to Eye Opening of Patients
Time to eye opening of patients was measured by the time from cessation of anesthesia administration to opening of the patients' eyes. After cessation of anesthesia, the investigators lightly tapped on the patients forehead or shoulder and asked the patients to open their eyes. This process was repeated about every minute until the patients opened their eyes.
Measured: Every minute after cessation of anesthesia until the patient opened his/her eyes
Time to Extubation of Patients
The time to extubation of patients was measured from cessation of anesthesia administration to tracheal extubation of the patient.
Measured: Every minute after cessation of anesthesia until the patient was extubated

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Nov 2010

First posted13 Sep 2010 (estimated)
Study startSep 2010
Primary completionNov 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
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: Case only
Time perspective: Prospective
Enrolment: 4,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01199471
Sponsor's protocol ID: P12-563
Status last verified: Jan 2012
First submitted: 31 Aug 2010
Last updated: 26 Jan 2012
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Anesthesia, General trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center Registry to Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane
ClinicalTrials.gov ID: NCT01199471
Acronym / sponsor ID: P12-563
Conditions: Anesthesia, General
Keywords: Sevoflurane, Physician's Practice Patterns, Economics, Pharmaceutical, Chinese
Study type: Observational
Recruitment status: Completed
Enrolment: 4,000 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Collaborators: Rundo-Cronova International Pharmaceuticals Research & Development Co., Ltd.
Study start: Sep 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 13 Sep 2010 (estimated)
Results: Posted 6 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Chinese Patients Requiring Surgery with Anesthesia	–	–Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia (sevoflurane) administered per local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA).

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Chinese patients undergoing surgery requiring general anesthesia with endotracheal intubation or laryngeal mask airway

Key inclusion criteria (3 listed)

ASA (American Society of Anesthesiologists) physical status (a requirement of the patient's physical status): I to III
Age from 18 to 70 years
Surgery requiring general anesthesia with endotracheal intubation or laryngeal mask airway.

Key exclusion criteria (5 listed)

History of significant cardiovascular, pulmonary, renal, hepatic or central nervous system disease or muscle disease.
Hypersensitivity or unusual response to any halogenated anesthetics.
Personal or familial history of malignant hyperthermia.
Female patients either pregnant or breast feeding.
General anesthesia is administered with total intravenous anesthesia (TIVA) of propofol.

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

Anesthesiologist Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)
Time frame: Within 24 hours
Anesthesiologist satisfaction with the anesthesia administered to each patient during surgery was recorded at the end of the operation using a Numeric Analog Scale (NAS) from 0 (not satisfied at all) to 10 (completely satisfied) are summarized.
Patient Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)
Time frame: Within 24 hours
Patient satisfaction with the anesthesia recorded at the end of the operation within 24 hours using a numeric analog scale (NAS) from 0 (not satisfied at all) to 10 (completely satisfied) are summarized.

4 secondary outcomes

Time to Loss of Consciousness of Patients Administered Anesthesia
Time frame: Up to 10 minutes
Time to Intubation of Patients
Time frame: Up to 10 minutes
Time to Eye Opening of Patients
Time frame: Every minute after cessation of anesthesia until the patient opened his/her eyes
Time to Extubation of Patients
Time frame: Every minute after cessation of anesthesia until the patient was extubated

Results and safety

Results posted to the registry on 6 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chinese Patients Requiring Surgery With Anesthesia	4,000	3,994

Primary outcome: Anesthesiologist Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)

Time frame: Within 24 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Chinese Patients Requiring Surgery With Anesthesia n = 3993
Value	8.85 (0.96)

Population analysed: 400 participating anesthesiologists evaluated their satisfaction with anesthesia (sevoflurane) administered to patients during surgery. All available data for 3,993 patients are included and summarized.

Primary outcome: Patient Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)

Time frame: Within 24 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Chinese Patients Requiring Surgery With Anesthesia n = 3972
Value	8.88 (0.93)

Population analysed: All available data were included in the analysis.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events experienced by patients that occurred during the course of the study were reported. Adverse events occurring during the study were reported up to 30 days after the last dose of study treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chinese Patients Requiring Surgery With Anesthesia	0 of 3,997 (0%)	43 of 3,997 (1.1%)	Not reported

Limitations and caveats (from the sponsor): Types of surgery not restricted/stratified in the study and no standard practice in China on inhalation and intravenous anesthesia methods may skew/bias results. Gaps in study design and multiple outcome parameters make drawing conclusions difficult.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Anesthesia, General

Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
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RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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Not yet recruitingPhase 4
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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.

Yue Kang, MD study director

Abbott

40 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia, General, run by Abbott at 40 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 3 inclusion and 5 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 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 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?

Yes. Results are posted in the registry (first posted 6 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Anesthesiologist Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS) (time frame: Within 24 hours). The study lists 2 primary outcomes in all. 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 NCT01199471.

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 26 Jan 2012.