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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
  Purpose

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.


Condition
Anesthesia, General

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multi-center Registry to Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 4000
Study Start Date: September 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199471

Locations
China, Guangdong
Site Reference ID/Investigator# 43073
Guangzhou, Guangdong, China, 510120
Site Reference ID/Investigator# 43076
Guangzhou, Guangdong, China, 510515
Site Reference ID/Investigator# 43077
Guangzhou, Guangdong, China, 528000
Site Reference ID/Investigator# 46407
Guangzhou, Guangdong, China, 510220
Site Reference ID/Investigator# 43072
Guangzhou, Guangdong, China, 510150
China, Heilongjiang
Site Reference ID/Investigator# 43066
Harbin, Heilongjiang, China, 150001
Site Reference ID/Investigator# 43068
Harbin, Heilongjiang, China, 150001
China, Hubei
Site Reference ID/Investigator# 43071
Wuhan, Hubei, China, 430060
Site Reference ID/Investigator# 43070
Wuhan, Hubei, China
China, Sichuan
Site Reference ID/Investigator# 43064
Chengdu, Sichuan, China, 610083
Site Reference ID/Investigator# 43065
Chengdu, Sichuan, China, 610072
China
Site Reference ID/Investigator# 43060
Beijing, China, 100035
Site Reference ID/Investigator# 43058
Beijing, China, 100044
Site Reference ID/Investigator# 43059
Beijing, China, 100081
Site Reference ID/Investigator# 46406
Beijing, China, 100039
Site Reference ID/Investigator# 43061
Beijing, China, 100730
Site Reference ID/Investigator# 43062
Beijing, China, 100191
Site Reference ID/Investigator# 43063
Beijing, China, 100700
Site Reference ID/Investigator# 44382
Beijing, China, 100050
Site Reference ID/Investigator# 43056
Beijing, China, 100029
Site Reference ID/Investigator# 43057
Beining, China, 100037
Site Reference ID/Investigator# 44384
Daqing, China, 163316
Site Reference ID/Investigator# 44383
Guangzhou, China, 510260
Site Reference ID/Investigator# 43074
Guangzhou, China, 510630
Site Reference ID/Investigator# 43067
Harbin, China, 150040
Site Reference ID/Investigator# 43051
Jiangsu, China, 210002
Site Reference ID/Investigator# 43011
Shanghai, China, 200127
Site Reference ID/Investigator# 41554
Shanghai, China, 200025
Site Reference ID/Investigator# 43012
Shanghai, China, 200080
Site Reference ID/Investigator# 43014
Shanghai, China, 200092
Site Reference ID/Investigator# 43015
Shanghai, China, 200003
Site Reference ID/Investigator# 43017
Shanghai, China, 200011
Site Reference ID/Investigator# 43018
Shanghai, China, 200433
Site Reference ID/Investigator# 46404
Shanghai, China, 200438
Site Reference ID/Investigator# 46405
Shanghai, China, 200040
Site Reference ID/Investigator# 43069
Wuhan, Hubei, China, 430022
Site Reference ID/Investigator# 43052
Zhejiang, China, 310003
Site Reference ID/Investigator# 43053
Zhejiang, China, 310009
Site Reference ID/Investigator# 43054
Zhejiang, China, 310016
Site Reference ID/Investigator# 43055
Zhejiang, China, 310022
Sponsors and Collaborators
Abbott
Rundo-Cronova International Pharmaceuticals Research & Development Co., Ltd.
Investigators
Study Director: Yue Kang, MD Abbott
  More Information

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

Keywords provided by Abbott:
Sevoflurane
Physician's Practice Patterns
Economics, Pharmaceutical
Chinese

Additional relevant MeSH terms:
Anesthetics
Sevoflurane
Anesthetics, General
Anesthetics, Inhalation
Central Nervous System Agents
Central Nervous System Depressants
Hematologic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014