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OpenTrials
Completed

NCT Number: NCT01715857

Clinical Practice of Inhalation Anesthesia With Sevoflurane in China

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.

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Key information

Conditions

Anesthesia, General

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Site Reference ID/Investigator# 84317, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Anesthesiologist Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)

    Time frame: 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.

  2. Participant Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)

    Time frame: 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 outcomes

  1. Time to Eye Opening

    Time frame: 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.

  2. Time to Extubation

    Time frame: 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.

  3. Cost of Anesthetics Including Sevoflurane (Yuan Renminbi [RMB]/Hour)

    Time frame: 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.

  4. Non-compliance of Sevoflurane End Tidal Concentration Following the Consensus

    Time frame: 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.

  5. Non-compliance of Sevoflurane Vaporizer Setting Following the Consensus

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 29, 2012
Registry last updated
Aug 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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