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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 24 hours after end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From cessation of sevoflurane administration until the participant opened their eyes, up to 80 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Chinese patients undergoing surgery require general anesthesia (sevoflurane) with endotracheal intubation or laryngeal mask.
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| Name | Affiliation | Role |
|---|---|---|
| Yue Kang, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 84317 | Beijing | 100000 | China | |||
| Site Reference ID/Investigator# 86755 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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. | 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. | 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. | 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. | During maintenance (up to 5 hours) |
| Beijing |
| 100029 |
| China |
| Site Reference ID/Investigator# 96155 | Beijing | 100191 | China |
| Site Reference ID/Investigator# 84320 | Beijing | 100730 | China |
| Site Reference ID/Investigator# 84316 | Beijing, Xicheng District | 100044 | China |
| Site Reference ID/Investigator# 84321 | Changchun, Jilin | 130031 | China |
| Site Reference ID/Investigator# 86754 | Changchun, Jilin | 130033 | China |
| Site Reference ID/Investigator# 86764 | Changsha, Hunan | 410008 | China |
| Site Reference ID/Investigator# 86767 | Changsha, Hunan | 410013 | China |
| Site Reference ID/Investigator# 100206 | Chengdu | 610041 | China |
| Site Reference ID/Investigator# 86762 | Chongqing | 400042 | China |
| Site Reference ID/Investigator# 84338 | Guangzhou | 510030 | China |
| Site Reference ID/Investigator# 106416 | Guangzhou | 510405 | China |
| Site Reference ID/Investigator# 84337 | Guangzhou | 510515 | China |
| Site Reference ID/Investigator# 102457 | Guangzhou | 511400 | China |
| Site Reference ID/Investigator# 84333 | Guangzhou, Guangdong | 510010 | China |
| Site Reference ID/Investigator# 100095 | Guangzhou, Guangdong | 510655 | China |
| Site Reference ID/Investigator# 84334 | Harbin, Heilongjiang | 150081 | China |
| Site Reference ID/Investigator# 86759 | Jinan, Shandong | 250014 | China |
| Site Reference ID/Investigator# 84318 | Kunming, Yunnan | 650032 | China |
| Site Reference ID/Investigator# 86757 | Kunming, Yunnan | 650101 | China |
| Site Reference ID/Investigator# 84336 | Lanzhou, Gansu | 730000 | China |
| Site Reference ID/Investigator# 84322 | Lanzhou, Gansu | 730030 | China |
| Site Reference ID/Investigator# 86761 | Nanchang, Jiangxi | 330006 | China |
| Site Reference ID/Investigator# 102455 | Qingdao | 266011 | China |
| Site Reference ID/Investigator# 78434 | Shanghai | 200025 | China |
| Site Reference ID/Investigator# 86073 | Shanghai | 200127 | China |
| Site Reference ID/Investigator# 84342 | Shanghai | 200438 | China |
| Site Reference ID/Investigator# 84314 | Shenyang, Liao Ning | 110042 | China |
| Site Reference ID/Investigator# 84319 | Shijiazhuang Hebei | 500011 | China |
| Site Reference ID/Investigator# 100207 | Tianjin | 300052 | China |
| Site Reference ID/Investigator# 95295 | Tianjin | 300162 | China |
| Site Reference ID/Investigator# 86760 | Wuhan, Hubei | 430022 | China |
| Site Reference ID/Investigator# 86766 | Zhengzhou, Henan | 450000 | China |
| Site Reference ID/Investigator# 86763 | Zhengzhou, Henan | 450008 | China |
| Site Reference ID/Investigator# 86769 | Zunyi, Guizhou | 563099 | China |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| American Society of Anesthesiologist (ASA) Physical Status | ASA Physical Status Classification System: ASA Physical Status I = A normal healthy patient; ASA Physical Status II = A patient with mild systemic disease; ASA Physical Status III = A patient with severe systemic disease; ASA Physical Status IV = A patient with severe systemic disease that is a constant threat to life; ASA Physical Status V = A moribund patient who is not expected to survive without the operation; ASA Physical Status VI = A declared brain-dead patient whose organs are being removed for donor purposes | Number | percentage of participants |
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| Type of Surgery | Number | percentage of participants |
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| Body Weight | Mean | Standard Deviation | kilograms |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | scores on a scale | End of surgery |
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| Primary | 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). | All participants who received study drug and with available data. | Posted | Mean | Standard Deviation | scores on a scale | 24 hours after end of surgery |
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| Secondary | 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. | All participants who received study drug and with available data. | Posted | Mean | Standard Deviation | minutes | From cessation of sevoflurane administration until the participant opened their eyes, up to 80 minutes |
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| Secondary | 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. | All participants who received study drug and with available data. | Posted | Mean | Standard Deviation | minutes | From cessation of sevoflurane administration until tracheal extubation occurred, up to 80 minutes |
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| Secondary | 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. | All participants who received study drug and with available data. | Posted | Mean | Standard Deviation | Yuan renminbi [RMB]/hour | Anesthetic duration between 1 to 5 hours |
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| Secondary | 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. | All participants who received study drug and with available data. | Posted | Number | percentage of timepoints | During maintenance (up to 5 hours) | Timepoints for Maintenance Period | Participants |
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| Secondary | 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. | All participants who received study drug and with available data. | Posted | Number | percentage of timepoints | During maintenance (up to 5 hours) | Timepoints During Maintenance | Participants |
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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).
Spontaneous adverse events (AEs) were also to be collected from the time the physician obtained the participant's informed consent until 30 days following treatment (total of approximately 31 days); there were no spontaneously reported AEs from the registry.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 4,004 | 0 | 4,004 |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| Title | Measurements |
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| ASA Physical Status III |
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| ASA Physical Status IV |
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| ASA Physical Status V |
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| Orthopedic Surgery |
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| Timepoints for Maintenance Period |
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