N/A
N=4,100
Clinical Practice of Inhalation Anesthesia With Sevoflurane in China
Anesthesia, General
Bottom Line
View on ClinicalTrials.gov: NCT01715857 ↗Enrolled (actual)
4,100
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Anesthesiologist Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS) — 9.14 scores on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anesthesiologist Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS) |
9.14 | — |
| PRIMARY Participant Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS) |
9.21 | — |
| SECONDARY Time to Eye Opening |
17.30 | — |
| SECONDARY Time to Extubation |
20.28 | — |
| SECONDARY Cost of Anesthetics Including Sevoflurane (Yuan Renminbi [RMB]/Hour) |
249.79 | — |
| SECONDARY Non-compliance of Sevoflurane End Tidal Concentration Following the Consensus |
17.82 | — |
| SECONDARY Non-compliance of Sevoflurane Vaporizer Setting Following the Consensus |
42.31 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01715857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.