Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane

A Multi-center Registry to Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane

This registry is primarily aiming to demonstrate the correlation between good practices of anesthesiologists and patient related outcomes including decreased overall anesthesia cost. The investigators would also like to demonstrate how the training background, and experience in inhalational anesthesia of the anesthesiologist influence their daily practice. At the end of the registry, the investigators would be able to demonstrate the influence of different practice pattern on patient related outcomes between the sites at which anesthesiologists follow modern anesthesiology practice based on their training/experience background and at which anesthesiologists do not follow same type of practice due to lack of their inhalational anesthesia training/experience.

Study Overview

• Status: Completed
• Conditions: Anesthesia, General

• Study Type: Observational
• Enrollment (Actual): 4000

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100029
    • Site Reference ID/Investigator# 43056
  • Beijing, China, 100035
    • Site Reference ID/Investigator# 43060
  • Beijing, China, 100039
    • Site Reference ID/Investigator# 46406
  • Beijing, China, 100044
    • Site Reference ID/Investigator# 43058
  • Beijing, China, 100050
    • Site Reference ID/Investigator# 44382
  • Beijing, China, 100081
    • Site Reference ID/Investigator# 43059
  • Beijing, China, 100191
    • Site Reference ID/Investigator# 43062
  • Beijing, China, 100700
    • Site Reference ID/Investigator# 43063
  • Beijing, China, 100730
    • Site Reference ID/Investigator# 43061
  • Beining, China, 100037
    • Site Reference ID/Investigator# 43057
  • Daqing, China, 163316
    • Site Reference ID/Investigator# 44384
  • Guangzhou, China, 510260
    • Site Reference ID/Investigator# 44383
  • Guangzhou, China, 510630
    • Site Reference ID/Investigator# 43074
  • Harbin, China, 150040
    • Site Reference ID/Investigator# 43067
  • Jiangsu, China, 210002
    • Site Reference ID/Investigator# 43051
  • Shanghai, China, 200003
    • Site Reference ID/Investigator# 43015
  • Shanghai, China, 200011
    • Site Reference ID/Investigator# 43017
  • Shanghai, China, 200025
    • Site Reference ID/Investigator# 41554
  • Shanghai, China, 200040
    • Site Reference ID/Investigator# 46405
  • Shanghai, China, 200080
    • Site Reference ID/Investigator# 43012
  • Shanghai, China, 200092
    • Site Reference ID/Investigator# 43014
  • Shanghai, China, 200127
    • Site Reference ID/Investigator# 43011
  • Shanghai, China, 200433
    • Site Reference ID/Investigator# 43018
  • Shanghai, China, 200438
    • Site Reference ID/Investigator# 46404
  • Wuhan, Hubei, China, 430022
    • Site Reference ID/Investigator# 43069
  • Zhejiang, China, 310003
    • Site Reference ID/Investigator# 43052
  • Zhejiang, China, 310009
    • Site Reference ID/Investigator# 43053
  • Zhejiang, China, 310016
    • Site Reference ID/Investigator# 43054
  • Zhejiang, China, 310022
    • Site Reference ID/Investigator# 43055
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Site Reference ID/Investigator# 43073
    • Guangzhou, Guangdong, China, 510150
      • Site Reference ID/Investigator# 43072
    • Guangzhou, Guangdong, China, 510220
      • Site Reference ID/Investigator# 46407
    • Guangzhou, Guangdong, China, 510515
      • Site Reference ID/Investigator# 43076
    • Guangzhou, Guangdong, China, 528000
      • Site Reference ID/Investigator# 43077
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • Site Reference ID/Investigator# 43066
    • Harbin, Heilongjiang, China, 150001
      • Site Reference ID/Investigator# 43068
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Site Reference ID/Investigator# 43071
    • Wuhan, Hubei, China
      • Site Reference ID/Investigator# 43070
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Site Reference ID/Investigator# 43065
    • Chengdu, Sichuan, China, 610083
      • Site Reference ID/Investigator# 43064

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chinese patients undergoing surgery requiring general anesthesia with endotracheal intubation or laryngeal mask airway

Description

Inclusion Criteria:

1. ASA (American Society of Anesthesiologists) physical status (a requirement of the patient's physical status): I to III
2. Age from 18 to 70 years
3. Surgery requiring general anesthesia with endotracheal intubation or laryngeal mask airway.

Exclusion Criteria:

1. History of significant cardiovascular, pulmonary, renal, hepatic or central nervous system disease or muscle disease.
2. Hypersensitivity or unusual response to any halogenated anesthetics.
3. Personal or familial history of malignant hyperthermia.
4. Female patients either pregnant or breast feeding.
5. General anesthesia is administered with total intravenous anesthesia (TIVA) of propofol.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Chinese Patients Requiring Surgery with Anesthesia; Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia (sevoflurane) administered per local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthesiologist Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)	Anesthesiologist satisfaction with the anesthesia administered to each patient during surgery was recorded at the end of the operation using a Numeric Analog Scale (NAS) from 0 (not satisfied at all) to 10 (completely satisfied) are summarized.	Within 24 hours
Patient Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)	Patient satisfaction with the anesthesia recorded at the end of the operation within 24 hours using a numeric analog scale (NAS) from 0 (not satisfied at all) to 10 (completely satisfied) are summarized.	Within 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Loss of Consciousness of Patients Administered Anesthesia	The time to loss of consciousness was measured from commencement of administration of anesthesia to the patient's loss of consciousness (no response to command).	Up to 10 minutes
Time to Intubation of Patients	The time to intubation of the patients was measured from the commencement of administration of anesthesia to intubation of each patient.	Up to 10 minutes
Time to Eye Opening of Patients	Time to eye opening of patients was measured by the time from cessation of anesthesia administration to opening of the patients' eyes. After cessation of anesthesia, the investigators lightly tapped on the patients forehead or shoulder and asked the patients to open their eyes. This process was repeated about every minute until the patients opened their eyes.	Every minute after cessation of anesthesia until the patient opened his/her eyes
Time to Extubation of Patients	The time to extubation of patients was measured from cessation of anesthesia administration to tracheal extubation of the patient.	Every minute after cessation of anesthesia until the patient was extubated

Collaborators and Investigators

• Sponsor: Abbott
• Collaborators: Rundo-Cronova International Pharmaceuticals Research & Development Co., Ltd.
• Investigators: Study Director: Yue Kang, MD, Abbott

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: August 31, 2010
• First Submitted That Met QC Criteria: September 9, 2010
• First Posted (Estimate): September 13, 2010

Study Record Updates

• Last Update Posted (Estimate): January 26, 2012
• Last Update Submitted That Met QC Criteria: January 24, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Chinese; Sevoflurane; Physician's Practice Patterns; Economics, Pharmaceutical
• Other Study ID Numbers: P12-563

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No