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Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane

This study has been completed.
Sponsor:
Collaborator:
Rundo-Cronova International Pharmaceuticals Research & Development Co., Ltd.
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01199471
First received: August 31, 2010
Last updated: January 24, 2012
Last verified: January 2012
Results First Received: November 30, 2011  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Anesthesia, General

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Chinese Patients Requiring Surgery With Anesthesia  
STARTED     4000 [1]
COMPLETED     3994  
NOT COMPLETED     6  
Protocol Violation                 4  
Withdrawal by Subject                 1  
Physician Decision                 1  
[1] 3 patients who did not meet ASA Physical Status Class 1 - 3 were excluded from all analyses.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
    Chinese Patients Requiring Surgery With Anesthesia  
Number of Participants  
[units: participants]
  3997  
Age  
[units: years]
Median ( Inter-Quartile Range )
  46  
  ( 35 to 56 )  
Age  
[units: years]
Mean ± Standard Deviation
  45.26  ± 13.52  
Gender  
[units: participants]
 
Female     2344  
Male     1653  
Region of Enrollment  
[units: participants]
 
China     3997  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Anesthesiologist Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)   [ Time Frame: Within 24 hours ]

2.  Primary:   Patient Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)   [ Time Frame: Within 24 hours ]

3.  Secondary:   Time to Loss of Consciousness of Patients Administered Anesthesia   [ Time Frame: Up to 10 minutes ]

4.  Secondary:   Time to Intubation of Patients   [ Time Frame: Up to 10 minutes ]

5.  Secondary:   Time to Eye Opening of Patients   [ Time Frame: Every minute after cessation of anesthesia until the patient opened his/her eyes ]

6.  Secondary:   Time to Extubation of Patients   [ Time Frame: Every minute after cessation of anesthesia until the patient was extubated ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Types of surgery not restricted/stratified in the study and no standard practice in China on inhalation and intravenous anesthesia methods may skew/bias results. Gaps in study design and multiple outcome parameters make drawing conclusions difficult.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott
phone: 800-633-9110


No publications provided


Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01199471     History of Changes
Other Study ID Numbers: P12-563
Study First Received: August 31, 2010
Results First Received: November 30, 2011
Last Updated: January 24, 2012
Health Authority: China: Food and Drug Administration