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Unhealthy Alcohol Drinking and Anesthetic Requirement in Women (UNADAREW)

Primary Purpose

General Anesthesia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Alcohol drinking
Alcohol drinking
Alcohol drinking
Alcohol drinking
Alcohol drinking
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for General Anesthesia focused on measuring Anesthetics, Sedatives, Analgesics

Eligibility Criteria

19 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanjing Maternal and Child Health Care Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

5

Arm Description

No alcohol drinking

Mild alcohol drinking

Moderate alcohol drinking

Severe over alcohol drinking

Alcohol-dependent

Outcomes

Primary Outcome Measures

Anesthetic requirements

Secondary Outcome Measures

Economic assessment
Odds Ratio of alcohol use and the consumption of anesthetics
Side effects
Bispectral Index (BIS) value

Full Information

First Posted
August 20, 2008
Last Updated
July 14, 2009
Sponsor
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00741507
Brief Title
Unhealthy Alcohol Drinking and Anesthetic Requirement in Women
Acronym
UNADAREW
Official Title
Unhealthy Alcohol Drinking and Anesthetic Requirement in General Anesthesia in Women
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Anesthesia
Keywords
Anesthetics, Sedatives, Analgesics

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
No alcohol drinking
Arm Title
2
Arm Type
Active Comparator
Arm Description
Mild alcohol drinking
Arm Title
3
Arm Type
Active Comparator
Arm Description
Moderate alcohol drinking
Arm Title
4
Arm Type
Active Comparator
Arm Description
Severe over alcohol drinking
Arm Title
5
Arm Type
Active Comparator
Arm Description
Alcohol-dependent
Intervention Type
Behavioral
Intervention Name(s)
Alcohol drinking
Other Intervention Name(s)
Ethanol use
Intervention Description
Never drinking of alcohol
Intervention Type
Behavioral
Intervention Name(s)
Alcohol drinking
Other Intervention Name(s)
Ethanol use
Intervention Description
Mild drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Intervention Type
Behavioral
Intervention Name(s)
Alcohol drinking
Other Intervention Name(s)
Ethanol use
Intervention Description
Moderate drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Intervention Type
Behavioral
Intervention Name(s)
Alcohol drinking
Other Intervention Name(s)
Ethanol use
Intervention Description
Severe over drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Intervention Type
Behavioral
Intervention Name(s)
Alcohol drinking
Other Intervention Name(s)
Ethanol use
Intervention Description
Alcohol-dependent assessed by "alcohol use disorders identification test (AUDIT)"
Primary Outcome Measure Information:
Title
Anesthetic requirements
Time Frame
10 min after completion of operation
Secondary Outcome Measure Information:
Title
Economic assessment
Time Frame
1 day after operation
Title
Odds Ratio of alcohol use and the consumption of anesthetics
Time Frame
1 day after completion of study
Title
Side effects
Time Frame
30 min after completion of the study
Title
Bispectral Index (BIS) value
Time Frame
0, 5, 10, 20, 30, 45, 60, 90 min after anesthesia

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XiaoFeng Shen, MD
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing Maternal and Child Health Care Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China

12. IPD Sharing Statement

Learn more about this trial

Unhealthy Alcohol Drinking and Anesthetic Requirement in Women

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