Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane
This study has been completed.
Sponsor:
Abbott
Collaborator:
Rundo-Cronova International Pharmaceuticals Research & Development Co., Ltd.
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01199471
First received: August 31, 2010
Last updated: January 24, 2012
Last verified: January 2012
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Purpose
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.
| Condition |
|---|
|
Anesthesia, General |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A Multi-center Registry to Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane |
Resource links provided by NLM:
Further study details as provided by Abbott:
Primary Outcome Measures:
- Anesthesiologist Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS) [ Time Frame: Within 24 hours ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Time to Loss of Consciousness of Patients Administered Anesthesia [ Time Frame: Up to 10 minutes ] [ Designated as safety issue: No ]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).
- Time to Intubation of Patients [ Time Frame: Up to 10 minutes ] [ Designated as safety issue: No ]The time to intubation of the patients was measured from the commencement of administration of anesthesia to intubation of each patient.
- Time to Eye Opening of Patients [ Time Frame: Every minute after cessation of anesthesia until the patient opened his/her eyes ] [ Designated as safety issue: No ]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.
- Time to Extubation of Patients [ Time Frame: Every minute after cessation of anesthesia until the patient was extubated ] [ Designated as safety issue: No ]The time to extubation of patients was measured from cessation of anesthesia administration to tracheal extubation of the patient.
| Enrollment: | 4000 |
| Study Start Date: | September 2010 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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).
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Chinese patients undergoing surgery requiring general anesthesia with endotracheal intubation or laryngeal mask airway
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199471
Locations
| China, Guangdong | |
| Site Reference ID/Investigator# 43073 | |
| Guangzhou, Guangdong, China, 510120 | |
| Site Reference ID/Investigator# 43072 | |
| Guangzhou, Guangdong, China, 510150 | |
| Site Reference ID/Investigator# 46407 | |
| Guangzhou, Guangdong, China, 510220 | |
| Site Reference ID/Investigator# 43076 | |
| Guangzhou, Guangdong, China, 510515 | |
| Site Reference ID/Investigator# 43077 | |
| Guangzhou, Guangdong, China, 528000 | |
| China, Heilongjiang | |
| Site Reference ID/Investigator# 43066 | |
| Harbin, Heilongjiang, China, 150001 | |
| Site Reference ID/Investigator# 43068 | |
| Harbin, Heilongjiang, China, 150001 | |
| China, Hubei | |
| Site Reference ID/Investigator# 43071 | |
| Wuhan, Hubei, China, 430060 | |
| Site Reference ID/Investigator# 43070 | |
| Wuhan, Hubei, China | |
| China, Sichuan | |
| Site Reference ID/Investigator# 43064 | |
| Chengdu, Sichuan, China, 610083 | |
| Site Reference ID/Investigator# 43065 | |
| Chengdu, Sichuan, China, 610072 | |
| China | |
| Site Reference ID/Investigator# 43059 | |
| Beijing, China, 100081 | |
| Site Reference ID/Investigator# 43056 | |
| Beijing, China, 100029 | |
| Site Reference ID/Investigator# 43060 | |
| Beijing, China, 100035 | |
| Site Reference ID/Investigator# 43063 | |
| Beijing, China, 100700 | |
| Site Reference ID/Investigator# 43061 | |
| Beijing, China, 100730 | |
| Site Reference ID/Investigator# 43062 | |
| Beijing, China, 100191 | |
| Site Reference ID/Investigator# 44382 | |
| Beijing, China, 100050 | |
| Site Reference ID/Investigator# 46406 | |
| Beijing, China, 100039 | |
| Site Reference ID/Investigator# 43058 | |
| Beijing, China, 100044 | |
| Site Reference ID/Investigator# 43057 | |
| Beining, China, 100037 | |
| Site Reference ID/Investigator# 44384 | |
| Daqing, China, 163316 | |
| Site Reference ID/Investigator# 43074 | |
| Guangzhou, China, 510630 | |
| Site Reference ID/Investigator# 44383 | |
| Guangzhou, China, 510260 | |
| Site Reference ID/Investigator# 43067 | |
| Harbin, China, 150040 | |
| Site Reference ID/Investigator# 43051 | |
| Jiangsu, China, 210002 | |
| Site Reference ID/Investigator# 46405 | |
| Shanghai, China, 200040 | |
| Site Reference ID/Investigator# 46404 | |
| Shanghai, China, 200438 | |
| Site Reference ID/Investigator# 41554 | |
| Shanghai, China, 200025 | |
| Site Reference ID/Investigator# 43018 | |
| Shanghai, China, 200433 | |
| Site Reference ID/Investigator# 43017 | |
| Shanghai, China, 200011 | |
| Site Reference ID/Investigator# 43015 | |
| Shanghai, China, 200003 | |
| Site Reference ID/Investigator# 43014 | |
| Shanghai, China, 200092 | |
| Site Reference ID/Investigator# 43012 | |
| Shanghai, China, 200080 | |
| Site Reference ID/Investigator# 43011 | |
| Shanghai, China, 200127 | |
| Site Reference ID/Investigator# 43069 | |
| Wuhan, Hubei, China, 430022 | |
| Site Reference ID/Investigator# 43052 | |
| Zhejiang, China, 310003 | |
| Site Reference ID/Investigator# 43055 | |
| Zhejiang, China, 310022 | |
| Site Reference ID/Investigator# 43054 | |
| Zhejiang, China, 310016 | |
| Site Reference ID/Investigator# 43053 | |
| Zhejiang, China, 310009 | |
Sponsors and Collaborators
Abbott
Rundo-Cronova International Pharmaceuticals Research & Development Co., Ltd.
Investigators
| Study Director: | Yue Kang, MD | Abbott |
More Information
No publications provided
| Responsible Party: | Abbott |
| ClinicalTrials.gov Identifier: | NCT01199471 History of Changes |
| Other Study ID Numbers: | P12-563 |
| Study First Received: | August 31, 2010 |
| Results First Received: | November 30, 2011 |
| Last Updated: | January 24, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Abbott:
|
Sevoflurane Physician's Practice Patterns Economics, Pharmaceutical Chinese |
Additional relevant MeSH terms:
|
Anesthetics Sevoflurane Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Platelet Aggregation Inhibitors Hematologic Agents Anesthetics, Inhalation Anesthetics, General |
ClinicalTrials.gov processed this record on May 22, 2013