Clinical Practice of Inhalation Anesthesia With Sevoflurane in China

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01715857
First received: September 2, 2012
Last updated: July 29, 2013
Last verified: July 2013
  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.


Enrollment: 4100
Study Start Date: July 2012
Study Completion Date: July 2013
Primary Completion Date: July 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:

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

Exclusion Criteria:

  1. History of clinically significant cardiovascular, pulmonary, renal, hepatic or central nervous system or muscle disease.
  2. Known hypersensitivity or history of unusual response to any halogenated anesthetics.
  3. Personal or familial history of malignant hyperthermia.
  4. Female patients who are either pregnant or breast feeding.
  5. General anesthesia is administered with total intravenous anesthesia (TIVA) of propofol or sevoflurane maintenance combined with propofol continuous infusion during maintenance.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715857

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

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01715857     History of Changes
Other Study ID Numbers: P13-934
Study First Received: September 2, 2012
Last Updated: July 29, 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 July 22, 2014