Clinical trial NCT01715857: Clinical Practice of Inhalation Anesthesia With Sevoflurane in China
Official title: A Multicenter Registry on the Clinical Practice of Inhalation Anesthesia With Sevoflurane in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, General
Keywords: Economics, Pharmaceutical
Physician's Practice Patterns
Chinese
Sevoflurane
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-10-29
Enrollment: 4100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese patients undergoing surgery require general anesthesia (sevoflurane) with endotracheal intubation or laryngeal mask.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Anesthesiologist Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)
timeFrame: End of surgery
measure: Participant Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)
timeFrame: 24 hours after end of surgery
Secondary outcomes:
measure: Time to Eye Opening
timeFrame: From cessation of sevoflurane administration until the participant opened their eyes, up to 80 minutes
measure: Time to Extubation
timeFrame: From cessation of sevoflurane administration until tracheal extubation occurred, up to 80 minutes
measure: Cost of Anesthetics Including Sevoflurane (Yuan Renminbi [RMB]/Hour)
timeFrame: Anesthetic duration between 1 to 5 hours
measure: Non-compliance of Sevoflurane End Tidal Concentration Following the Consensus
timeFrame: During maintenance (up to 5 hours)
measure: Non-compliance of Sevoflurane Vaporizer Setting Following the Consensus
timeFrame: During maintenance (up to 5 hours)
Other outcomes:
Locations:
city: Beijing, Xicheng District
country: China
facility: Site Reference ID/Investigator# 84316
city: Beijing
country: China
facility: Site Reference ID/Investigator# 84317
city: Beijing
country: China
facility: Site Reference ID/Investigator# 86755
city: Beijing
country: China
facility: Site Reference ID/Investigator# 96155
city: Beijing
country: China
facility: Site Reference ID/Investigator# 84320
city: Changchun, Jilin
country: China
facility: Site Reference ID/Investigator# 84321
city: Changchun, Jilin
country: China
facility: Site Reference ID/Investigator# 86754
city: Changsha, Hunan
country: China
facility: Site Reference ID/Investigator# 86764
city: Changsha, Hunan
country: China
facility: Site Reference ID/Investigator# 86767
city: Chengdu
country: China
facility: Site Reference ID/Investigator# 100206
city: Chongqing
country: China
facility: Site Reference ID/Investigator# 86762
city: Guangzhou, Guangdong
country: China
facility: Site Reference ID/Investigator# 84333
city: Guangzhou, Guangdong
country: China
facility: Site Reference ID/Investigator# 100095
city: Guangzhou
country: China
facility: Site Reference ID/Investigator# 84338
city: Guangzhou
country: China
facility: Site Reference ID/Investigator# 106416
city: Guangzhou
country: China
facility: Site Reference ID/Investigator# 84337
city: Guangzhou
country: China
facility: Site Reference ID/Investigator# 102457
city: Harbin, Heilongjiang
country: China
facility: Site Reference ID/Investigator# 84334
city: Jinan, Shandong
country: China
facility: Site Reference ID/Investigator# 86759
city: Kunming, Yunnan
country: China
facility: Site Reference ID/Investigator# 84318
city: Kunming, Yunnan
country: China
facility: Site Reference ID/Investigator# 86757
city: Lanzhou, Gansu
country: China
facility: Site Reference ID/Investigator# 84336
city: Lanzhou, Gansu
country: China
facility: Site Reference ID/Investigator# 84322
city: Nanchang, Jiangxi
country: China
facility: Site Reference ID/Investigator# 86761
city: Qingdao
country: China
facility: Site Reference ID/Investigator# 102455
city: Shanghai
country: China
facility: Site Reference ID/Investigator# 78434
city: Shanghai
country: China
facility: Site Reference ID/Investigator# 86073
city: Shanghai
country: China
facility: Site Reference ID/Investigator# 84342
city: Shenyang, Liao Ning
country: China
facility: Site Reference ID/Investigator# 84314
city: Shijiazhuang Hebei
country: China
facility: Site Reference ID/Investigator# 84319
city: Tianjin
country: China
facility: Site Reference ID/Investigator# 100207
city: Tianjin
country: China
facility: Site Reference ID/Investigator# 95295
city: Wuhan, Hubei
country: China
facility: Site Reference ID/Investigator# 86760
city: Zhengzhou, Henan
country: China
facility: Site Reference ID/Investigator# 86766
city: Zhengzhou, Henan
country: China
facility: Site Reference ID/Investigator# 86763
city: Zunyi, Guizhou
country: China
facility: Site Reference ID/Investigator# 86769
Study officials:
affiliation: AbbVie
name: Yue Kang, MD
role: STUDY_DIRECTOR
References: