Clinical Practice of Inhalation Anesthesia With Sevoflurane in China

A Multicenter Registry on the Clinical Practice of Inhalation Anesthesia With Sevoflurane in China

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, General

• Study Type: Observational
• Enrollment (Actual): 4100

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chinese patients undergoing surgery require general anesthesia (sevoflurane) with endotracheal intubation or laryngeal mask.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthesiologist Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)	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.	End of surgery
Participant Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)	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).	24 hours after end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Eye Opening	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.	From cessation of sevoflurane administration until the participant opened their eyes, up to 80 minutes
Time to Extubation	Time to extubation was measured from the time sevoflurane administration had stopped until tracheal extubation or laryngeal mask airway (LMA) removal occurred.	From cessation of sevoflurane administration until tracheal extubation occurred, up to 80 minutes
Cost of Anesthetics Including Sevoflurane (Yuan Renminbi [RMB]/Hour)	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.	Anesthetic duration between 1 to 5 hours
Non-compliance of Sevoflurane End Tidal Concentration Following the Consensus	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.	During maintenance (up to 5 hours)
Non-compliance of Sevoflurane Vaporizer Setting Following the Consensus	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.	During maintenance (up to 5 hours)

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)
• Investigators: Study Director: Yue Kang, MD, AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: September 2, 2012
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (Estimate): October 29, 2012

Study Record Updates

• Last Update Posted (Estimate): August 19, 2014
• Last Update Submitted That Met QC Criteria: August 15, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Chinese; Sevoflurane; Physician's Practice Patterns; Economics, Pharmaceutical
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: P13-934