Clinical Practice of Inhalation Anesthesia With Sevoflurane in China

AbbVie

Status: Completed

Conditions: Anesthesia, General

Study type: Observational

Funder types: Industry

Identifiers

NCT01715857

P13-934

Details and patient eligibility

About

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.

Enrollment: 4,100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

4,100 participants in 1 patient group

Chinese Patients Requiring Surgery with Sevoflurane Anesthesia

Description:

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