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: August 15, 2014
Last verified: August 2014
  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 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.


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 Using a Numeric Analog Scale (NAS) [ Time Frame: End of surgery ] [ Designated as safety issue: No ]
    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.

  • Participant Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS) [ Time Frame: 24 hours after end of surgery ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Time to Eye Opening [ Time Frame: From cessation of sevoflurane administration until the participant opened their eyes, up to 80 minutes ] [ Designated as safety issue: No ]
    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.

  • Time to Extubation [ Time Frame: From cessation of sevoflurane administration until tracheal extubation occurred, up to 80 minutes ] [ Designated as safety issue: No ]
    Time to extubation was measured from the time sevoflurane administration had stopped until tracheal extubation or laryngeal mask airway (LMA) removal occurred.

  • Cost of Anesthetics Including Sevoflurane (Yuan Renminbi [RMB]/Hour) [ 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 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.

  • Non-compliance of Sevoflurane End Tidal Concentration Following the Consensus [ Time Frame: During maintenance (up to 5 hours) ] [ Designated as safety issue: No ]
    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.

  • Non-compliance of Sevoflurane Vaporizer Setting Following the Consensus [ Time Frame: During maintenance (up to 5 hours) ] [ Designated as safety issue: No ]
    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.


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 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

  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. American Society of Anesthesiologists (ASA) physical status: I, II and III.
  3. Surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA).
  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# 84320
Beijing, China, 100730
Site Reference ID/Investigator# 86755
Beijing, China, 100029
Site Reference ID/Investigator# 84317
Beijing, China, 100000
Site Reference ID/Investigator# 96155
Beijing, China, 100191
Site Reference ID/Investigator# 84316
Beijing, Xicheng District, China, 100044
Site Reference ID/Investigator# 86754
Changchun, Jilin, China, 130033
Site Reference ID/Investigator# 84321
Changchun, Jilin, China, 130031
Site Reference ID/Investigator# 86767
Changsha, Hunan, China, 410013
Site Reference ID/Investigator# 86764
Changsha, Hunan, China, 410008
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# 106416
Guangzhou, China, 510405
Site Reference ID/Investigator# 84337
Guangzhou, China, 510515
Site Reference ID/Investigator# 84338
Guangzhou, China, 510030
Site Reference ID/Investigator# 84333
Guangzhou, Guangdong, China, 510010
Site Reference ID/Investigator# 100095
Guangzhou, Guangdong, China, 510655
Site Reference ID/Investigator# 84334
Harbin, Heilongjiang, China, 150081
Site Reference ID/Investigator# 86759
Jinan, Shandong, China, 250014
Site Reference ID/Investigator# 86757
Kunming, Yunnan, China, 650101
Site Reference ID/Investigator# 84318
Kunming, Yunnan, China, 650032
Site Reference ID/Investigator# 84322
Lanzhou, Gansu, China, 730030
Site Reference ID/Investigator# 84336
Lanzhou, Gansu, China, 730000
Site Reference ID/Investigator# 86761
Nanchang, Jiangxi, China, 330006
Site Reference ID/Investigator# 102455
Qingdao, China, 266011
Site Reference ID/Investigator# 84342
Shanghai, China, 200438
Site Reference ID/Investigator# 78434
Shanghai, China, 200025
Site Reference ID/Investigator# 86073
Shanghai, China, 200127
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
Results First Received: July 23, 2014
Last Updated: August 15, 2014
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 August 21, 2014