Clinical Practice of Inhalation Anesthesia With Sevoflurane in China

Study Overview
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Brief Summary
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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.

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

Conditions
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Anesthesia, General

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Man or woman, aged from 18 to 70 years old. American Society of Anesthesiologists (ASA) physical status: I, II and III. Surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA). The type of surgery is either general surgery, or orthopedics, or gynecology. The duration of anesthesia ranges from 1 to 5 hours. Exclusion Criteria: History of clinically significant cardiovascular, pulmonary, renal, hepatic or central nervous system or muscle disease. Known hypersensitivity or history of unusual response to any halogenated anesthetics. Personal or familial history of malignant hyperthermia. Female patients who are either pregnant or breast feeding. General anesthesia is administered with total intravenous anesthesia (TIVA) of propofol or sevoflurane maintenance combined with propofol continuous infusion during maintenance.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chinese Patients Requiring Surgery with Sevoflurane Anesthesia<br>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?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Economics, Pharmaceutical, Physician's Practice Patterns, Chinese, Sevoflurane