Unhealthy Alcohol Drinking and Anesthetic Requirement in Women (UNADAREW)

July 14, 2009 updated by: Nanjing Medical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210004
        • Nanjing Maternal and Child Health Care Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
No alcohol drinking
Behavioral: Alcohol drinking
Never drinking of alcohol
Other Names:
  • Ethanol use
Behavioral: Alcohol drinking
Mild drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Other Names:
  • Ethanol use
Behavioral: Alcohol drinking
Moderate drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Other Names:
  • Ethanol use
Behavioral: Alcohol drinking
Severe over drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Other Names:
  • Ethanol use
Behavioral: Alcohol drinking
Alcohol-dependent assessed by "alcohol use disorders identification test (AUDIT)"
Other Names:
  • Ethanol use
Active Comparator: 2
Mild alcohol drinking
Behavioral: Alcohol drinking
Never drinking of alcohol
Other Names:
  • Ethanol use
Behavioral: Alcohol drinking
Mild drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Other Names:
  • Ethanol use
Behavioral: Alcohol drinking
Moderate drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Other Names:
  • Ethanol use
Behavioral: Alcohol drinking
Severe over drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Other Names:
  • Ethanol use
Behavioral: Alcohol drinking
Alcohol-dependent assessed by "alcohol use disorders identification test (AUDIT)"
Other Names:
  • Ethanol use
Active Comparator: 3
Moderate alcohol drinking
Behavioral: Alcohol drinking
Never drinking of alcohol
Other Names:
  • Ethanol use
Behavioral: Alcohol drinking
Mild drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Other Names:
  • Ethanol use
Behavioral: Alcohol drinking
Moderate drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Other Names:
  • Ethanol use
Behavioral: Alcohol drinking
Severe over drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Other Names:
  • Ethanol use
Behavioral: Alcohol drinking
Alcohol-dependent assessed by "alcohol use disorders identification test (AUDIT)"
Other Names:
  • Ethanol use
Active Comparator: 4
Severe over alcohol drinking
Behavioral: Alcohol drinking
Never drinking of alcohol
Other Names:
  • Ethanol use
Behavioral: Alcohol drinking
Mild drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Other Names:
  • Ethanol use
Behavioral: Alcohol drinking
Moderate drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Other Names:
  • Ethanol use
Behavioral: Alcohol drinking
Severe over drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Other Names:
  • Ethanol use
Behavioral: Alcohol drinking
Alcohol-dependent assessed by "alcohol use disorders identification test (AUDIT)"
Other Names:
  • Ethanol use
Active Comparator: 5
Alcohol-dependent
Behavioral: Alcohol drinking
Never drinking of alcohol
Other Names:
  • Ethanol use
Behavioral: Alcohol drinking
Mild drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Other Names:
  • Ethanol use
Behavioral: Alcohol drinking
Moderate drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Other Names:
  • Ethanol use
Behavioral: Alcohol drinking
Severe over drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Other Names:
  • Ethanol use
Behavioral: Alcohol drinking
Alcohol-dependent assessed by "alcohol use disorders identification test (AUDIT)"
Other Names:
  • Ethanol use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anesthetic requirements
Time Frame: 10 min after completion of operation
10 min after completion of operation

Secondary Outcome Measures

Outcome Measure
Time Frame
Economic assessment
Time Frame: 1 day after operation
1 day after operation
Odds Ratio of alcohol use and the consumption of anesthetics
Time Frame: 1 day after completion of study
1 day after completion of study
Side effects
Time Frame: 30 min after completion of the study
30 min after completion of the study
Bispectral Index (BIS) value
Time Frame: 0, 5, 10, 20, 30, 45, 60, 90 min after anesthesia
0, 5, 10, 20, 30, 45, 60, 90 min after anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

August 20, 2008

First Submitted That Met QC Criteria

August 25, 2008

First Posted (Estimate)

August 26, 2008

Study Record Updates

Last Update Posted (Estimate)

July 15, 2009

Last Update Submitted That Met QC Criteria

July 14, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMU-FY2008-329
  • NJFY-230MZ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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