Unhealthy Alcohol Drinking and Anesthetic Requirement in Women
UNADAREW
2 other identifiers
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2008
CompletedFirst Posted
Study publicly available on registry
August 26, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedJuly 15, 2009
July 1, 2009
10 months
August 20, 2008
July 14, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anesthetic requirements
10 min after completion of operation
Secondary Outcomes (4)
Economic assessment
1 day after operation
Odds Ratio of alcohol use and the consumption of anesthetics
1 day after completion of study
Side effects
30 min after completion of the study
Bispectral Index (BIS) value
0, 5, 10, 20, 30, 45, 60, 90 min after anesthesia
Study Arms (5)
1
ACTIVE COMPARATORNo alcohol drinking
2
ACTIVE COMPARATORMild alcohol drinking
3
ACTIVE COMPARATORModerate alcohol drinking
4
ACTIVE COMPARATORSevere over alcohol drinking
5
ACTIVE COMPARATORAlcohol-dependent
Interventions
Eligibility Criteria
You may qualify if:
- ASA physical status I-II
- Chinese
- Undergoing general anesthesia
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, 210004, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
XiaoFeng Shen, MD
Nanjing Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 20, 2008
First Posted
August 26, 2008
Study Start
September 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
July 15, 2009
Record last verified: 2009-07