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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01199471

Enrollment

4000

Registered

2010-09-13

Start date

2010-09-30

Completion date

2010-11-30

Last updated

2012-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, General

Keywords

Sevoflurane, Physician's Practice Patterns, Economics, Pharmaceutical, Chinese

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Anesthesiologist Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)	Within 24 hours	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.
Patient Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)	Within 24 hours	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.

Secondary

Measure	Time frame	Description
Time to Loss of Consciousness of Patients Administered Anesthesia	Up to 10 minutes	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).
Time to Intubation of Patients	Up to 10 minutes	The time to intubation of the patients was measured from the commencement of administration of anesthesia to intubation of each patient.
Time to Eye Opening of Patients	Every minute after cessation of anesthesia until the patient opened his/her eyes	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.
Time to Extubation of Patients	Every minute after cessation of anesthesia until the patient was extubated	The time to extubation of patients was measured from cessation of anesthesia administration to tracheal extubation of the patient.

Countries

China

Participant flow

Participants by arm

Arm	Count
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 administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.	3,997
Total	3,997

Arm

Count

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 administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.

3,997

Total

3,997

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Physician Decision	1
Overall Study	Protocol Violation	4
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	Chinese Patients Requiring Surgery With Anesthesia
Age Continuous	45.26 years STANDARD_DEVIATION 13.52
Region of Enrollment China	3997 participants
Sex: Female, Male Female	2344 Participants
Sex: Female, Male Male	1653 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	43 / 3,997
serious Total, serious adverse events	0 / 3,997

Outcome results

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.

Time frame: Within 24 hours

Population: 400 participating anesthesiologists evaluated their satisfaction with anesthesia (sevoflurane) administered to patients during surgery. All available data for 3,993 patients are included and summarized.

Arm	Measure	Value (MEAN)	Dispersion
Chinese Patients Requiring Surgery With Anesthesia	Anesthesiologist Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)	8.85 units on a scale	Standard Deviation 0.96

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.

Time frame: Within 24 hours