Unhealthy Alcohol Drinking and Anesthetic Requirement in Women (UNADAREW)

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00741507
First received: August 20, 2008
Last updated: July 14, 2009
Last verified: July 2009

August 20, 2008
July 14, 2009
September 2008
July 2009   (final data collection date for primary outcome measure)
Anesthetic requirements [ Time Frame: 10 min after completion of operation ] [ Designated as safety issue: Yes ]
Anesthetic requirements [ Time Frame: During the whole process of anesthesia ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00741507 on ClinicalTrials.gov Archive Site
  • Economic assessment [ Time Frame: 1 day after operation ] [ Designated as safety issue: No ]
  • Odds Ratio of alcohol use and the consumption of anesthetics [ Time Frame: 1 day after completion of study ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: 30 min after completion of the study ] [ Designated as safety issue: Yes ]
  • Bispectral Index (BIS) value [ Time Frame: 0, 5, 10, 20, 30, 45, 60, 90 min after anesthesia ] [ Designated as safety issue: Yes ]
  • Economic assessment [ Time Frame: During the whole process of anesthesia ] [ Designated as safety issue: No ]
  • Odds Ratio of alcohol use and the consumption of anesthetics [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: During the whole period of the study ] [ Designated as safety issue: Yes ]
  • Bispectral Index (BIS) value [ Time Frame: During the whole period of anesthesia ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Unhealthy Alcohol Drinking and Anesthetic Requirement in Women
Unhealthy Alcohol Drinking and Anesthetic Requirement in General Anesthesia in Women

Unhealthy alcohol drinking is negatively influencing health of people and costing a large number of annual finance via "secondhand" effects. Additionally, unhealthy alcohol use covers a spectrum that is associated with varying degrees of risk to health. The investigators hypothesized that unhealthy alcohol drinking resulted in significant increase in anesthetic requirement during general anesthesia. This investigation would clarify the association between unhealthy alcohol use and the intraoperative consumption of anesthetics, and provide clinical evidence for preoperative assessment with respect to the alcohol drinking habit.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
General Anesthesia
  • Behavioral: Alcohol drinking
    Never drinking of alcohol
    Other Name: Ethanol use
  • Behavioral: Alcohol drinking
    Mild drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
    Other Name: Ethanol use
  • Behavioral: Alcohol drinking
    Moderate drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
    Other Name: Ethanol use
  • Behavioral: Alcohol drinking
    Severe over drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
    Other Name: Ethanol use
  • Behavioral: Alcohol drinking
    Alcohol-dependent assessed by "alcohol use disorders identification test (AUDIT)"
    Other Name: Ethanol use
  • Active Comparator: 1
    No alcohol drinking
    Intervention: Behavioral: Alcohol drinking
  • Active Comparator: 2
    Mild alcohol drinking
    Intervention: Behavioral: Alcohol drinking
  • Active Comparator: 3
    Moderate alcohol drinking
    Intervention: Behavioral: Alcohol drinking
  • Active Comparator: 4
    Severe over alcohol drinking
    Intervention: Behavioral: Alcohol drinking
  • Active Comparator: 5
    Alcohol-dependent
    Intervention: Behavioral: Alcohol drinking
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ASA physical status I-II
  • Chinese
  • 19-45yr
  • Undergoing general anesthesia

Exclusion Criteria:

  • A history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records.
  • Participants younger than 18yr,older than 45yr or pregnancy was eliminated.
  • Those who were not willing to or could not finish the whole study at any time.
Female
19 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00741507
NMU-FY2008-329, NJFY-230MZ
Yes
XiaoFeng Shen, Nanjing Medical University
Nanjing Medical University
Not Provided
Study Chair: XiaoFeng Shen, MD Nanjing Medical University
Nanjing Medical University
July 2009

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