Anesthesia, GeneralNCT01715857

Clinical Practice of Inhalation Anesthesia With Sevoflurane in China

An observational study of Anesthesia, General, run by AbbVie (prior sponsor, Abbott) at 36 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: 4,100 participants
Where: 36 sitesChina
Study dates: Jul 2012to Jul 2013
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 require general anesthesia (sevoflurane) with endotracheal intubation or laryngeal mask.

Who may be able to join

Man or woman, aged from 18 to 70 years old.
American Society of Anesthesiologists (ASA) physical status: I, II and III.
Surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA).
The type of surgery is either general surgery, or orthopedics, or gynecology.
The duration of anesthesia ranges from 1 to 5 hours.

Who cannot join

History of clinically significant cardiovascular, pulmonary, renal, hepatic or central nervous system or muscle disease.
Known hypersensitivity or history of unusual response to any halogenated anesthetics.
Personal or familial history of malignant hyperthermia.
Female patients who are either pregnant or breast feeding.
General anesthesia is administered with total intravenous anesthesia (TIVA) of propofol or sevoflurane maintenance combined with propofol continuous infusion during maintenance.

Trial locations and contacts

36 sites in 1 country.

City, postcode or hospital

36 sites in 1 country

China36 sites

Site Reference ID/Investigator# 84317
Beijing, 100000
Site Reference ID/Investigator# 86755
Beijing, 100029
Site Reference ID/Investigator# 96155
Beijing, 100191
Site Reference ID/Investigator# 84320
Beijing, 100730
Site Reference ID/Investigator# 84316
Beijing, Xicheng District, 100044
Site Reference ID/Investigator# 84321
Changchun, Jilin, 130031
Site Reference ID/Investigator# 86754
Changchun, Jilin, 130033
Site Reference ID/Investigator# 86764
Changsha, Hunan, 410008
Site Reference ID/Investigator# 86767
Changsha, Hunan, 410013
Site Reference ID/Investigator# 100206
Chengdu, 610041
Site Reference ID/Investigator# 86762
Chongqing, 400042
Site Reference ID/Investigator# 84338
Guangzhou, 510030
Site Reference ID/Investigator# 106416
Guangzhou, 510405
Site Reference ID/Investigator# 84337
Guangzhou, 510515
Site Reference ID/Investigator# 102457
Guangzhou, 511400
Site Reference ID/Investigator# 84333
Guangzhou, Guangdong, 510010
Site Reference ID/Investigator# 100095
Guangzhou, Guangdong, 510655
Site Reference ID/Investigator# 84334
Harbin, Heilongjiang, 150081
Site Reference ID/Investigator# 86759
Jinan, Shandong, 250014
Site Reference ID/Investigator# 84318
Kunming, Yunnan, 650032
Site Reference ID/Investigator# 86757
Kunming, Yunnan, 650101
Site Reference ID/Investigator# 84336
Lanzhou, Gansu, 730000
Site Reference ID/Investigator# 84322
Lanzhou, Gansu, 730030
Site Reference ID/Investigator# 86761
Nanchang, Jiangxi, 330006
Site Reference ID/Investigator# 102455
Qingdao, 266011
Site Reference ID/Investigator# 78434
Shanghai, 200025
Site Reference ID/Investigator# 86073
Shanghai, 200127
Site Reference ID/Investigator# 84342
Shanghai, 200438
Site Reference ID/Investigator# 84314
Shenyang, Liao Ning, 110042
Site Reference ID/Investigator# 84319
Shijiazhuang Hebei, 500011
Site Reference ID/Investigator# 100207
Tianjin, 300052
Site Reference ID/Investigator# 95295
Tianjin, 300162
Site Reference ID/Investigator# 86760
Wuhan, Hubei, 430022
Site Reference ID/Investigator# 86766
Zhengzhou, Henan, 450000
Site Reference ID/Investigator# 86763
Zhengzhou, Henan, 450008
Site Reference ID/Investigator# 86769
Zunyi, Guizhou, 563099

Other trials in China

About this study

Official title: A Multicenter Registry on the Clinical Practice of Inhalation Anesthesia With Sevoflurane in China

Until recently, there was a lack of understanding and consensus among Chinese anesthesiologists how they should practice general anesthesia with volatile anesthetics, since there was no standard of inhalation practice. In August 2011, the Anesthesiology branch of the Chinese Medical Association launched the first version of Chinese Consensus of Standard Clinical Practice for Inhalation Anesthesia (Consensus) in order to standardize the practice in China.

The proposed registry is aimed to evaluate the current inhalation practice one year after the Consensus has been released, and related patient outcome. This registry evaluated sevoflurane anesthesia, including screening, induction, maintenance, emergence, and follow-up within 24 hours post-operation.

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

What participants receive

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

Study groups in NCT01715857
Study group	Role	What they receive
Chinese Patients Requiring Surgery with Sevoflurane Anesthesia		Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China

What is being measured

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

Anesthesiologist Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)
Anesthesiologist satisfaction with the anesthesia was recorded by the anesthesiologist at the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied). The satisfaction of induction, maintenance, and emergence accounts for 20%, 50%, and 30% of the score, respectively.
Measured: End of surgery
Participant Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)
Participant satisfaction with the anesthesia recorded approximately 24 hours after the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied).
Measured: 24 hours after end of surgery

Secondary outcomes (5)

Time to Eye Opening
After cessation of anesthesia, the investigators lightly tapped on the participant's forehead or shoulder and asked the participant to open their eyes. This process was repeated approximately every minute until eye opening occurred.
Measured: From cessation of sevoflurane administration until the participant opened their eyes, up to 80 minutes
Time to Extubation
Time to extubation was measured from the time sevoflurane administration had stopped until tracheal extubation or laryngeal mask airway (LMA) removal occurred.
Measured: From cessation of sevoflurane administration until tracheal extubation occurred, up to 80 minutes
Cost of Anesthetics Including Sevoflurane (Yuan Renminbi [RMB]/Hour)
Cost of anesthetics is the sum of the cost of sevoflurane and other anesthetics including narcotics and muscle relaxants. Cost of sevoflurane = unit price of sevoflurane multiplied by the used volume of sevoflurane. Cost of other anesthetics = unit price of anesthetics multiplied by the total volume of anesthetics in the ampoule.
Measured: Anesthetic duration between 1 to 5 hours
Non-compliance of Sevoflurane End Tidal Concentration Following the Consensus
Non-compliance of sevoflurane end tidal concentration was defined as the percentage of time points for the maintenance period (excluding washout phase) that were below the sevoflurane end tidal concentration boundary of 0.6 minimal alveolar concentration (MAC) based on the Consensus. A higher percentage indicates a higher degree of non-compliance.
Measured: During maintenance (up to 5 hours)
Non-compliance of Sevoflurane Vaporizer Setting Following the Consensus
Non-compliance of sevoflurane vaporizer setting was defined as the percentage of time points for the maintenance period outside the range of 1.0 - 1.5 minimal alveolar concentration (MAC) during the maintenance period (excluding washout phase) based on the Consensus. A higher percentage indicates a higher degree of non-compliance.
Measured: During maintenance (up to 5 hours)

Timeline

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

Jul 2012Jul 2013

First posted29 Oct 2012 (estimated)
Study startJul 2012
Primary completionJul 2013
Study completionJul 2013

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: 4,100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01715857
Sponsor's protocol ID: P13-934
Status last verified: Aug 2014
First submitted: 2 Sep 2012
Last updated: 19 Aug 2014
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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Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Registry on the Clinical Practice of Inhalation Anesthesia With Sevoflurane in China
ClinicalTrials.gov ID: NCT01715857
Acronym / sponsor ID: P13-934
Conditions: Anesthesia, General
Keywords: Economics, Pharmaceutical, Physician's Practice Patterns, Chinese, Sevoflurane
Study type: Observational
Recruitment status: Completed
Enrolment: 4,100 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 29 Oct 2012 (estimated)
Results: Posted 13 Aug 2014

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 Sevoflurane Anesthesia	–	–Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China

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 require general anesthesia (sevoflurane) with endotracheal intubation or laryngeal mask.

Key inclusion criteria (5 listed)

Man or woman, aged from 18 to 70 years old.
American Society of Anesthesiologists (ASA) physical status: I, II and III.
Surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA).
The type of surgery is either general surgery, or orthopedics, or gynecology.
The duration of anesthesia ranges from 1 to 5 hours.

Key exclusion criteria (5 listed)

History of clinically significant cardiovascular, pulmonary, renal, hepatic or central nervous system or muscle disease.
Known hypersensitivity or history of unusual response to any halogenated anesthetics.
Personal or familial history of malignant hyperthermia.
Female patients who are either pregnant or breast feeding.
General anesthesia is administered with total intravenous anesthesia (TIVA) of propofol or sevoflurane maintenance combined with propofol continuous infusion during maintenance.

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 Using a Numeric Analog Scale (NAS)
Time frame: End of surgery
Anesthesiologist satisfaction with the anesthesia was recorded by the anesthesiologist at the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied). The satisfaction of induction, maintenance, and emergence accounts for 20%, 50%, and 30% of the score, respectively.
Participant Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)
Time frame: 24 hours after end of surgery
Participant satisfaction with the anesthesia recorded approximately 24 hours after the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied).

5 secondary outcomes

Time to Eye Opening
Time frame: From cessation of sevoflurane administration until the participant opened their eyes, up to 80 minutes
Time to Extubation
Time frame: From cessation of sevoflurane administration until tracheal extubation occurred, up to 80 minutes
Cost of Anesthetics Including Sevoflurane (Yuan Renminbi [RMB]/Hour)
Time frame: Anesthetic duration between 1 to 5 hours
Non-compliance of Sevoflurane End Tidal Concentration Following the Consensus
Time frame: During maintenance (up to 5 hours)
Non-compliance of Sevoflurane Vaporizer Setting Following the Consensus
Time frame: During maintenance (up to 5 hours)

Results and safety

Results posted to the registry on 13 Aug 2014, 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 Sevoflurane Anesthesia	4,100	4,004

Primary outcome: Anesthesiologist Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)

Time frame: End of surgery. Mean (Standard Deviation). Unit: scores on a scale

Measure	Chinese Patients Requiring Surgery With Sevoflurane Anesthesia n = 4004
Value	9.14 (0.85)

Primary outcome: Participant Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)

Time frame: 24 hours after end of surgery. Mean (Standard Deviation). Unit: scores on a scale

Measure	Chinese Patients Requiring Surgery With Sevoflurane Anesthesia n = 4004
Value	9.21 (0.91)

Population analysed: All participants who received study drug and with available data.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: All serious adverse events (SAEs) were required to be collected in the registry from the time the physician obtained the participant's informed consent until 30 days following treatment (approximately 31 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chinese Patients Requiring Surgery With Sevoflurane Anesthesia	0 of 4,004 (0%)	0 of 4,004 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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

AbbVie

36 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 AbbVie (prior sponsor, Abbott) at 36 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 5 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 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 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 13 Aug 2014). 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 Using a Numeric Analog Scale (NAS) (time frame: End of surgery). 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 NCT01715857.

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 19 Aug 2014.