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Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane

24. januar 2012 opdateret af: Abbott

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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

4000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
      • Beijing, Kina, 100029
        • Site Reference ID/Investigator# 43056
      • Beijing, Kina, 100035
        • Site Reference ID/Investigator# 43060
      • Beijing, Kina, 100039
        • Site Reference ID/Investigator# 46406
      • Beijing, Kina, 100044
        • Site Reference ID/Investigator# 43058
      • Beijing, Kina, 100050
        • Site Reference ID/Investigator# 44382
      • Beijing, Kina, 100081
        • Site Reference ID/Investigator# 43059
      • Beijing, Kina, 100191
        • Site Reference ID/Investigator# 43062
      • Beijing, Kina, 100700
        • Site Reference ID/Investigator# 43063
      • Beijing, Kina, 100730
        • Site Reference ID/Investigator# 43061
      • Beining, Kina, 100037
        • Site Reference ID/Investigator# 43057
      • Daqing, Kina, 163316
        • Site Reference ID/Investigator# 44384
      • Guangzhou, Kina, 510260
        • Site Reference ID/Investigator# 44383
      • Guangzhou, Kina, 510630
        • Site Reference ID/Investigator# 43074
      • Harbin, Kina, 150040
        • Site Reference ID/Investigator# 43067
      • Jiangsu, Kina, 210002
        • Site Reference ID/Investigator# 43051
      • Shanghai, Kina, 200003
        • Site Reference ID/Investigator# 43015
      • Shanghai, Kina, 200011
        • Site Reference ID/Investigator# 43017
      • Shanghai, Kina, 200025
        • Site Reference ID/Investigator# 41554
      • Shanghai, Kina, 200040
        • Site Reference ID/Investigator# 46405
      • Shanghai, Kina, 200080
        • Site Reference ID/Investigator# 43012
      • Shanghai, Kina, 200092
        • Site Reference ID/Investigator# 43014
      • Shanghai, Kina, 200127
        • Site Reference ID/Investigator# 43011
      • Shanghai, Kina, 200433
        • Site Reference ID/Investigator# 43018
      • Shanghai, Kina, 200438
        • Site Reference ID/Investigator# 46404
      • Wuhan, Hubei, Kina, 430022
        • Site Reference ID/Investigator# 43069
      • Zhejiang, Kina, 310003
        • Site Reference ID/Investigator# 43052
      • Zhejiang, Kina, 310009
        • Site Reference ID/Investigator# 43053
      • Zhejiang, Kina, 310016
        • Site Reference ID/Investigator# 43054
      • Zhejiang, Kina, 310022
        • Site Reference ID/Investigator# 43055
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510120
        • Site Reference ID/Investigator# 43073
      • Guangzhou, Guangdong, Kina, 510150
        • Site Reference ID/Investigator# 43072
      • Guangzhou, Guangdong, Kina, 510220
        • Site Reference ID/Investigator# 46407
      • Guangzhou, Guangdong, Kina, 510515
        • Site Reference ID/Investigator# 43076
      • Guangzhou, Guangdong, Kina, 528000
        • Site Reference ID/Investigator# 43077
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150001
        • Site Reference ID/Investigator# 43066
      • Harbin, Heilongjiang, Kina, 150001
        • Site Reference ID/Investigator# 43068
    • Hubei
      • Wuhan, Hubei, Kina, 430060
        • Site Reference ID/Investigator# 43071
      • Wuhan, Hubei, Kina
        • Site Reference ID/Investigator# 43070
    • Sichuan
      • Chengdu, Sichuan, Kina, 610072
        • Site Reference ID/Investigator# 43065
      • Chengdu, Sichuan, Kina, 610083
        • Site Reference ID/Investigator# 43064

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kun etui
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Anesthesiologist Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)
Tidsramme: 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.
Within 24 hours
Patient Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)
Tidsramme: 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.
Within 24 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Loss of Consciousness of Patients Administered Anesthesia
Tidsramme: 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).
Up to 10 minutes
Time to Intubation of Patients
Tidsramme: 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.
Up to 10 minutes
Time to Eye Opening of Patients
Tidsramme: 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.
Every minute after cessation of anesthesia until the patient opened his/her eyes
Time to Extubation of Patients
Tidsramme: 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.
Every minute after cessation of anesthesia until the patient was extubated

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Abbott

Samarbejdspartnere

Rundo-Cronova International Pharmaceuticals Research & Development Co., Ltd.

Efterforskere

  • Studieleder: Yue Kang, MD, Abbott

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2010

Primær færdiggørelse (Faktiske)

1. november 2010

Studieafslutning (Faktiske)

1. november 2010

Datoer for studieregistrering

Først indsendt

31. august 2010

Først indsendt, der opfyldte QC-kriterier

9. september 2010

Først opslået (Skøn)

13. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. januar 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. januar 2012

Sidst verificeret

1. januar 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • P12-563

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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