Clinical Practice of Inhalation Anesthesia With Sevoflurane in China
This study is currently recruiting participants.
Verified March 2013 by AbbVie
Sponsor:
Abbott (China)
Information provided by (Responsible Party):
AbbVie ( Abbott (China) )
ClinicalTrials.gov Identifier:
NCT01715857
First received: September 2, 2012
Last updated: March 12, 2013
Last verified: March 2013
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Purpose
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 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.
| Condition |
|---|
|
Anesthesia, General |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A Multicenter Registry on the Clinical Practice of Inhalation Anesthesia With Sevoflurane in China |
Resource links provided by NLM:
Further study details as provided by AbbVie:
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 will be recorded at the end of the operation using a Numeric Analog Scale (NAS) from 0 (not satisfied at all) to 10 (completely satisfied)
- Patient satisfaction with the anesthesia recorded at 24 hours after the end of the operation using a Numeric Analog Scale (NAS) [ Time Frame: Within 48 hours ] [ Designated as safety issue: No ]Patient satisfaction with the anesthesia will be recorded approximately 24 hours after the end of the operation using a Numeric Analog Scale (NAS) from 0 (not satisfied at all) to 10 (completely satisfied)
Secondary Outcome Measures:
- Time to eye opening [ Time Frame: Every minute after cessation of anesthesia until the patient open his/her eyes, up to 80 minutes ] [ Designated as safety issue: No ]After cessation of anesthesia, the investigators lightly tapped on the patients forehead or shoulder and asked the patients to open their eyes. This process is repeated approximately every minute until eye opening occurred.
- Time to extubation [ Time Frame: Every minute after cessation of anesthesia until tracheal extubation occurs, up to 80 minutes ] [ Designated as safety issue: No ]
- Cost of anesthetics [ Time Frame: Anesthetic duration between 1 to 5 hours ] [ Designated as safety issue: No ]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 x used volume of sevoflurane. Cost of other anesthetics = unit price of anesthetics x total volume of anesthetics in the ampoule.
| Estimated Enrollment: | 4000 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Chinese Patients Requiring Surgery with Anesthesia |
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 require general anesthesia (sevoflurane) with endotracheal intubation or laryngeal mask.
Criteria
Inclusion Criteria:
- Man or woman, aged from 18 to 70 years old.
- ASA (American society of anesthesiologists) physical status: I, II and III.
- Surgery requiring sevoflurane anesthesia with endotracheal intubation or LMA (laryngeal mask).
- The type of surgery is either general surgery, or orthopedics, or gynecology.
- The duration of anesthesia ranges from 1 to 5 hours.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715857
Contacts
| Contact: Xi Zhang, MD | 8621 62631365 | xi.zhang@abbott.com |
| Contact: Yue Kang, MD | 8621 62631384 | yue.kang@abbott.com |
Locations
| China | |
| Site Reference ID/Investigator# 84316 | Completed |
| Beijing, China, 100044 | |
| Site Reference ID/Investigator# 84317 | Recruiting |
| Beijing, China, 100000 | |
| Principal Investigator: Site Reference ID/Investigator# 84317 | |
| Site Reference ID/Investigator# 84321 | Completed |
| Changchuan, Jining, China, 130031 | |
| Site Reference ID/Investigator# 86762 | Completed |
| Chongqing, China, 400042 | |
| Site Reference ID/Investigator# 84337 | Recruiting |
| Guangzhou, Guangdong, China, 510515 | |
| Principal Investigator: Site Reference ID/Investigator# 84337 | |
| Site Reference ID/Investigator# 84338 | Recruiting |
| Guangzhou, Guangdong, China, 510030 | |
| Principal Investigator: Site Reference ID/Investigator# 84338 | |
| Site Reference ID/Investigator# 84333 | Recruiting |
| Guangzhou, Guangdong, China, 510010 | |
| Principal Investigator: Site Reference ID/Investigator# 84333 | |
| Site Reference ID/Investigator# 84334 | Recruiting |
| Harbin, Heilongjiang, China, 150081 | |
| Principal Investigator: Site Reference ID/Investigator# 84334 | |
| Site Reference ID/Investigator# 86759 | Completed |
| Jinan, Shandong, China, 250014 | |
| Site Reference ID/Investigator# 84336 | Recruiting |
| Lanzhou, Gansu, China, 730000 | |
| Principal Investigator: Site Reference ID/Investigator# 84336 | |
| Site Reference ID/Investigator# 84322 | Recruiting |
| Lanzhou, Gansu, China, 730030 | |
| Principal Investigator: Site Reference ID/Investigator# 84322 | |
| Site Reference ID/Investigator# 86761 | Recruiting |
| Nanchang, Jiangxi, China, 330006 | |
| Principal Investigator: Site Reference ID/Investigator# 86761 | |
| Site Reference ID/Investigator# 84342 | Recruiting |
| Shanghai, China, 200438 | |
| Principal Investigator: Site Reference ID/Investigator# 84342 | |
| Site Reference ID/Investigator# 78434 | Completed |
| Shanghai, China, 200025 | |
| Site Reference ID/Investigator# 84319 | Recruiting |
| Shijiazhuang Hebei, China, 500011 | |
| Principal Investigator: Site Reference ID/Investigator# 84319 | |
| Site Reference ID/Investigator# 86760 | Completed |
| Wuhan, Hubei, China, 430022 | |
| Site Reference ID/Investigator# 86766 | Recruiting |
| Zhengzhou, Henan, China, 450000 | |
| Principal Investigator: Site Reference ID/Investigator# 86766 | |
| Site Reference ID/Investigator# 86763 | Completed |
| Zhengzhou, Henan, China, 450008 | |
| Site Reference ID/Investigator# 86769 | Completed |
| Zunyi, Guizhou, China, 563099 | |
Sponsors and Collaborators
Abbott (China)
Investigators
| Study Director: | Yue Kang, MD | Abbott |
More Information
No publications provided
| Responsible Party: | AbbVie ( Abbott (China) ) |
| ClinicalTrials.gov Identifier: | NCT01715857 History of Changes |
| Other Study ID Numbers: | P13-934 |
| Study First Received: | September 2, 2012 |
| Last Updated: | March 12, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by AbbVie:
|
Economics Pharmaceutical Physician's Practice Patterns Chinese Sevoflurane |
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 16, 2013