Clinical Practice of Inhalation Anesthesia With Sevoflurane in China

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01715857

Enrollment

4100

Registered

2012-10-29

Start date

2012-07-31

Completion date

2013-07-31

Last updated

2014-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, General

Keywords

Economics, Pharmaceutical, Physician's Practice Patterns, Chinese, Sevoflurane

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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 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.
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.

Countries

China

Participant flow

Participants by arm

Arm	Count
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	4,004
Total	4,004

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Did Not Meet Eligibility Criteria	96

Baseline characteristics

Characteristic	Chinese Patients Requiring Surgery With Sevoflurane Anesthesia
Age, Continuous	45.54 years STANDARD_DEVIATION 12.57
American Society of Anesthesiologist (ASA) Physical Status ASA Physical Status I	47.33 percentage of participants
American Society of Anesthesiologist (ASA) Physical Status ASA Physical Status II	49.18 percentage of participants
American Society of Anesthesiologist (ASA) Physical Status ASA Physical Status III	3.50 percentage of participants
American Society of Anesthesiologist (ASA) Physical Status ASA Physical Status IV	0 percentage of participants
American Society of Anesthesiologist (ASA) Physical Status ASA Physical Status V	0 percentage of participants
Body Weight	62.19 kilograms STANDARD_DEVIATION 10.96
Sex: Female, Male Female	2720 Participants
Sex: Female, Male Male	1284 Participants
Type of Surgery General Surgery	55.09 percentage of participants
Type of Surgery Gynecologic Surgery	28.17 percentage of participants
Type of Surgery Orthopedic Surgery	16.73 percentage of participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 4,004
serious Total, serious adverse events	0 / 4,004

Outcome results

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.

Time frame: End of surgery

Arm	Measure	Value (MEAN)	Dispersion
Chinese Patients Requiring Surgery With Sevoflurane Anesthesia	Anesthesiologist Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)	9.14 scores on a scale	Standard Deviation 0.85

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).

Time frame: 24 hours after end of surgery