Clinical Practice of Inhalation Anesthesia With Sevoflurane in China

Completed

• Conditions: Anesthesia, General

• Registration Number: NCT01715857
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-09-02
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-29
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2014-07-23
• Results First Submitted QC: 2014-07-23
• Status Verified: 2014-08
• Results First Posted: 2014-08-13
• Last Update Submitted: 2014-08-15
• Last Update Posted: 2014-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anesthesiologist Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)	End of surgery	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)	24 hours after end of surgery	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

Name	Time	Method
Time to Eye Opening	From cessation of sevoflurane administration until the participant opened their eyes, up to 80 minutes	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.
Non-compliance of Sevoflurane End Tidal Concentration Following the Consensus	During maintenance (up to 5 hours)	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.
Time to Extubation	From cessation of sevoflurane administration until tracheal extubation occurred, up to 80 minutes	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)	Anesthetic duration between 1 to 5 hours	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 Vaporizer Setting Following the Consensus	During maintenance (up to 5 hours)	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.

Trial Locations

Locations (36)

Site Reference ID/Investigator# 84316; 🇨🇳 Beijing, Xicheng District, China

Site Reference ID/Investigator# 86755; 🇨🇳 Beijing, China

Site Reference ID/Investigator# 96155; 🇨🇳 Beijing, China

Site Reference ID/Investigator# 84317; 🇨🇳 Beijing, China

Site Reference ID/Investigator# 84320; 🇨🇳 Beijing, China

Site Reference ID/Investigator# 84321; 🇨🇳 Changchun, Jilin, China

Site Reference ID/Investigator# 86764; 🇨🇳 Changsha, Hunan, China

Site Reference ID/Investigator# 86754; 🇨🇳 Changchun, Jilin, China

Site Reference ID/Investigator# 86767; 🇨🇳 Changsha, Hunan, China

Site Reference ID/Investigator# 100206; 🇨🇳 Chengdu, China

Site Reference ID/Investigator# 100095; 🇨🇳 Guangzhou, Guangdong, 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# 84334; 🇨🇳 Harbin, Heilongjiang, China

Site Reference ID/Investigator# 84318; 🇨🇳 Kunming, Yunnan, China

Site Reference ID/Investigator# 86757; 🇨🇳 Kunming, Yunnan, China

Site Reference ID/Investigator# 84336; 🇨🇳 Lanzhou, Gansu, China

Site Reference ID/Investigator# 84322; 🇨🇳 Lanzhou, Gansu, China

Site Reference ID/Investigator# 102455; 🇨🇳 Qingdao, China

Site Reference ID/Investigator# 78434; 🇨🇳 Shanghai, China

Site Reference ID/Investigator# 86073; 🇨🇳 Shanghai, 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# 86762; 🇨🇳 Chongqing, China

Site Reference ID/Investigator# 84333; 🇨🇳 Guangzhou, Guangdong, China

Site Reference ID/Investigator# 102457; 🇨🇳 Guangzhou, China

Site Reference ID/Investigator# 86761; 🇨🇳 Nanchang, Jiangxi, China

Site Reference ID/Investigator# 84342; 🇨🇳 Shanghai, China

Site Reference ID/Investigator# 84314; 🇨🇳 Shenyang, Liao Ning, China

Site Reference ID/Investigator# 86769; 🇨🇳 Zunyi, Guizhou, China

Site Reference ID/Investigator# 86759; 🇨🇳 Jinan, Shandong, China