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

August 31, 2010
January 24, 2012
September 2010
November 2010   (final data collection date for primary outcome measure)
  • Anesthesiologist Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS) [ Time Frame: Within 24 hours ] [ Designated as safety issue: No ]
    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) [ Time Frame: Within 24 hours ] [ Designated as safety issue: No ]
    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.
  • NAS (Numeric Analog Scale) [ Time Frame: Within 24 hours ] [ Designated as safety issue: No ]
    Anesthesiologist satisfaction recorded at the end of operation.
  • NAS (Numeric Analog Scale) [ Time Frame: Within 24 hours ] [ Designated as safety issue: No ]
    Patient satisfaction recorded within 24 hours.
Complete list of historical versions of study NCT01199471 on ClinicalTrials.gov Archive Site
  • Time to Loss of Consciousness of Patients Administered Anesthesia [ Time Frame: Up to 10 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 10 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Every minute after cessation of anesthesia until the patient opened his/her eyes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Every minute after cessation of anesthesia until the patient was extubated ] [ Designated as safety issue: No ]
    The time to extubation of patients was measured from cessation of anesthesia administration to tracheal extubation of the patient.
  • Time to loss of consciousness [ Time Frame: Up to 10 minutes ] [ Designated as safety issue: No ]
    Measured by the time from the commence of investigate drug administration to loss of consciousness (response to command).
  • Time to intubation [ Time Frame: Up to 10 minutes ] [ Designated as safety issue: No ]
    measured by the time from the commence of investigate drug administration to intubation
  • Time to eye opening [ Time Frame: Up to 10 minutes ] [ Designated as safety issue: No ]
    Measured by the time from cessation of sevoflurane or propofol administration to opening of eyes. Approximately 5 minutes after anesthesia cessation, the investigators lightly tap on the patient's forehead or shoulder and ask the patient to open their eyes. This process will be repeated about every minute until the patient follows the command.
  • Time to extubation [ Time Frame: Up to 10 minutes ] [ Designated as safety issue: No ]
    The time from cessation of sevoflurane or propofol administration to tracheal extubation
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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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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

Anesthesia, General
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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).
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4000
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01199471
P12-563
Not Provided
Abbott
Abbott
Rundo-Cronova International Pharmaceuticals Research & Development Co., Ltd.
Study Director: Yue Kang, MD Abbott
Abbott
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP