Clinical Practice of Inhalation Anesthesia With Sevoflurane in China

Anesthesia, General Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715857
• Other study ID #: P13-934
• Status: Completed
• Phase: N/A
• First received: September 2, 2012
• Last updated: August 15, 2014
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: August 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4100
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia, General

Locations

Country	Name	City	State
China	Site Reference ID/Investigator# 84317	Beijing
China	Site Reference ID/Investigator# 84320	Beijing
China	Site Reference ID/Investigator# 86755	Beijing
China	Site Reference ID/Investigator# 96155	Beijing
China	Site Reference ID/Investigator# 84316	Beijing, Xicheng District
China	Site Reference ID/Investigator# 84321	Changchun, Jilin
China	Site Reference ID/Investigator# 86754	Changchun, Jilin
China	Site Reference ID/Investigator# 86764	Changsha, Hunan
China	Site Reference ID/Investigator# 86767	Changsha, Hunan
China	Site Reference ID/Investigator# 100206	Chengdu
China	Site Reference ID/Investigator# 86762	Chongqing
China	Site Reference ID/Investigator# 102457	Guangzhou
China	Site Reference ID/Investigator# 106416	Guangzhou
China	Site Reference ID/Investigator# 84337	Guangzhou
China	Site Reference ID/Investigator# 84338	Guangzhou
China	Site Reference ID/Investigator# 100095	Guangzhou, Guangdong
China	Site Reference ID/Investigator# 84333	Guangzhou, Guangdong
China	Site Reference ID/Investigator# 84334	Harbin, Heilongjiang
China	Site Reference ID/Investigator# 86759	Jinan, Shandong
China	Site Reference ID/Investigator# 84318	Kunming, Yunnan
China	Site Reference ID/Investigator# 86757	Kunming, Yunnan
China	Site Reference ID/Investigator# 84322	Lanzhou, Gansu
China	Site Reference ID/Investigator# 84336	Lanzhou, Gansu
China	Site Reference ID/Investigator# 86761	Nanchang, Jiangxi
China	Site Reference ID/Investigator# 102455	Qingdao
China	Site Reference ID/Investigator# 78434	Shanghai
China	Site Reference ID/Investigator# 84342	Shanghai
China	Site Reference ID/Investigator# 86073	Shanghai
China	Site Reference ID/Investigator# 84314	Shenyang, Liao Ning
China	Site Reference ID/Investigator# 84319	Shijiazhuang Hebei
China	Site Reference ID/Investigator# 100207	Tianjin
China	Site Reference ID/Investigator# 95295	Tianjin
China	Site Reference ID/Investigator# 86760	Wuhan, Hubei
China	Site Reference ID/Investigator# 86763	Zhengzhou, Henan
China	Site Reference ID/Investigator# 86766	Zhengzhou, Henan
China	Site Reference ID/Investigator# 86769	Zunyi, Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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)	No

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