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| Name | Class |
|---|---|
| Rundo-Cronova International Pharmaceuticals Research & Development Co., Ltd. | UNKNOWN |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Within 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 10 minutes |
| Time to Intubation of Patients |
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Inclusion Criteria:
Exclusion Criteria:
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Chinese patients undergoing surgery requiring general anesthesia with endotracheal intubation or laryngeal mask airway
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| Name | Affiliation | Role |
|---|---|---|
| Yue Kang, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 43073 | Guangzhou | Guangdong | 510120 | China | ||
| Site Reference ID/Investigator# 43072 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The time to intubation of the patients was measured from the commencement of administration of anesthesia to intubation of each patient. |
| 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. | 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. | Every minute after cessation of anesthesia until the patient was extubated |
| Guangzhou |
| Guangdong |
| 510150 |
| China |
| Site Reference ID/Investigator# 46407 | Guangzhou | Guangdong | 510220 | China |
| Site Reference ID/Investigator# 43076 | Guangzhou | Guangdong | 510515 | China |
| Site Reference ID/Investigator# 43077 | Guangzhou | Guangdong | 528000 | China |
| Site Reference ID/Investigator# 43066 | Harbin | Heilongjiang | 150001 | China |
| Site Reference ID/Investigator# 43068 | Harbin | Heilongjiang | 150001 | China |
| Site Reference ID/Investigator# 43071 | Wuhan | Hubei | 430060 | China |
| Site Reference ID/Investigator# 43070 | Wuhan | Hubei | China |
| Site Reference ID/Investigator# 43065 | Chengdu | Sichuan | 610072 | China |
| Site Reference ID/Investigator# 43064 | Chengdu | Sichuan | 610083 | China |
| Site Reference ID/Investigator# 43056 | Beijing | 100029 | China |
| Site Reference ID/Investigator# 43060 | Beijing | 100035 | China |
| Site Reference ID/Investigator# 46406 | Beijing | 100039 | China |
| Site Reference ID/Investigator# 43058 | Beijing | 100044 | China |
| Site Reference ID/Investigator# 44382 | Beijing | 100050 | China |
| Site Reference ID/Investigator# 43059 | Beijing | 100081 | China |
| Site Reference ID/Investigator# 43062 | Beijing | 100191 | China |
| Site Reference ID/Investigator# 43063 | Beijing | 100700 | China |
| Site Reference ID/Investigator# 43061 | Beijing | 100730 | China |
| Site Reference ID/Investigator# 43057 | Beining | 100037 | China |
| Site Reference ID/Investigator# 44384 | Daqing | 163316 | China |
| Site Reference ID/Investigator# 44383 | Guangzhou | 510260 | China |
| Site Reference ID/Investigator# 43074 | Guangzhou | 510630 | China |
| Site Reference ID/Investigator# 43067 | Harbin | 150040 | China |
| Site Reference ID/Investigator# 43051 | Jiangsu | 210002 | China |
| Site Reference ID/Investigator# 43015 | Shanghai | 200003 | China |
| Site Reference ID/Investigator# 43017 | Shanghai | 200011 | China |
| Site Reference ID/Investigator# 41554 | Shanghai | 200025 | China |
| Site Reference ID/Investigator# 46405 | Shanghai | 200040 | China |
| Site Reference ID/Investigator# 43012 | Shanghai | 200080 | China |
| Site Reference ID/Investigator# 43014 | Shanghai | 200092 | China |
| Site Reference ID/Investigator# 43011 | Shanghai | 200127 | China |
| Site Reference ID/Investigator# 43018 | Shanghai | 200433 | China |
| Site Reference ID/Investigator# 46404 | Shanghai | 200438 | China |
| Site Reference ID/Investigator# 43069 | Wuhan, Hubei | 430022 | China |
| Site Reference ID/Investigator# 43052 | Zhejiang | 310003 | China |
| Site Reference ID/Investigator# 43053 | Zhejiang | 310009 | China |
| Site Reference ID/Investigator# 43054 | Zhejiang | 310016 | China |
| Site Reference ID/Investigator# 43055 | Zhejiang | 310022 | China |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Within 24 hours |
|
|
| |||||||||||||||||||||||||
| Primary | 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. | All available data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Within 24 hours |
|
| ||||||||||||||||||||||||||
| Secondary | 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). | All available data were included in the analysis. | Posted | Mean | Standard Deviation | minutes | Up to 10 minutes |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | All available data were included in the analysis. | Posted | Mean | Standard Deviation | minutes | Up to 10 minutes |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | All available data were included in the analysis. | Posted | Mean | Standard Deviation | minutes | Every minute after cessation of anesthesia until the patient opened his/her eyes |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Extubation of Patients | The time to extubation of patients was measured from cessation of anesthesia administration to tracheal extubation of the patient. | All available data were included in the analysis. | Posted | Mean | Standard Deviation | minutes | Every minute after cessation of anesthesia until the patient was extubated |
|
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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.
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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 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 administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3. | 0 | 3,997 | 43 | 3,997 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Postoperative nausea and vomiting | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Allergic reaction | Immune system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Asthma | Immune system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Slow heart rhythm | Investigations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Agitation during the operation | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Emergence agitation | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
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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.
Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 800-633-9110 |
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