Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane

Anesthesia, General Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199471
• Other study ID #: P12-563
• Status: Completed
• Phase: N/A
• First received: August 31, 2010
• Last updated: January 24, 2012
• Start date: September 2010
• Est. completion date: November 2010

Study information

• Verified date: January 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia, General

Locations

Country	Name	City	State
China	Site Reference ID/Investigator# 43056	Beijing
China	Site Reference ID/Investigator# 43058	Beijing
China	Site Reference ID/Investigator# 43059	Beijing
China	Site Reference ID/Investigator# 43060	Beijing
China	Site Reference ID/Investigator# 43061	Beijing
China	Site Reference ID/Investigator# 43062	Beijing
China	Site Reference ID/Investigator# 43063	Beijing
China	Site Reference ID/Investigator# 44382	Beijing
China	Site Reference ID/Investigator# 46406	Beijing
China	Site Reference ID/Investigator# 43057	Beining
China	Site Reference ID/Investigator# 43064	Chengdu	Sichuan
China	Site Reference ID/Investigator# 43065	Chengdu	Sichuan
China	Site Reference ID/Investigator# 44384	Daqing
China	Site Reference ID/Investigator# 43072	Guangzhou	Guangdong
China	Site Reference ID/Investigator# 43073	Guangzhou	Guangdong
China	Site Reference ID/Investigator# 43074	Guangzhou
China	Site Reference ID/Investigator# 43076	Guangzhou	Guangdong
China	Site Reference ID/Investigator# 43077	Guangzhou	Guangdong
China	Site Reference ID/Investigator# 44383	Guangzhou
China	Site Reference ID/Investigator# 46407	Guangzhou	Guangdong
China	Site Reference ID/Investigator# 43066	Harbin	Heilongjiang
China	Site Reference ID/Investigator# 43067	Harbin
China	Site Reference ID/Investigator# 43068	Harbin	Heilongjiang
China	Site Reference ID/Investigator# 43051	Jiangsu
China	Site Reference ID/Investigator# 41554	Shanghai
China	Site Reference ID/Investigator# 43011	Shanghai
China	Site Reference ID/Investigator# 43012	Shanghai
China	Site Reference ID/Investigator# 43014	Shanghai
China	Site Reference ID/Investigator# 43015	Shanghai
China	Site Reference ID/Investigator# 43017	Shanghai
China	Site Reference ID/Investigator# 43018	Shanghai
China	Site Reference ID/Investigator# 46404	Shanghai
China	Site Reference ID/Investigator# 46405	Shanghai
China	Site Reference ID/Investigator# 43070	Wuhan	Hubei
China	Site Reference ID/Investigator# 43071	Wuhan	Hubei
China	Site Reference ID/Investigator# 43069	Wuhan, Hubei
China	Site Reference ID/Investigator# 43052	Zhejiang
China	Site Reference ID/Investigator# 43053	Zhejiang
China	Site Reference ID/Investigator# 43054	Zhejiang
China	Site Reference ID/Investigator# 43055	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Rundo-Cronova International Pharmaceuticals Research & Development Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No