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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00741507
Other study ID # NMU-FY2008-329
Secondary ID NJFY-230MZ
Status Completed
Phase N/A
First received August 20, 2008
Last updated July 14, 2009
Start date September 2008
Est. completion date July 2009

Study information

Verified date July 2009
Source Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 45 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening


Related Conditions & MeSH terms


Intervention

Behavioral:
Alcohol drinking
Never drinking of alcohol
Alcohol drinking
Mild drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Alcohol drinking
Moderate drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Alcohol drinking
Severe over drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Alcohol drinking
Alcohol-dependent assessed by "alcohol use disorders identification test (AUDIT)"

Locations

Country Name City State
China Nanjing Maternal and Child Health Care Hospital Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anesthetic requirements 10 min after completion of operation Yes
Secondary Economic assessment 1 day after operation No
Secondary Odds Ratio of alcohol use and the consumption of anesthetics 1 day after completion of study No
Secondary Side effects 30 min after completion of the study Yes
Secondary Bispectral Index (BIS) value 0, 5, 10, 20, 30, 45, 60, 90 min after anesthesia Yes
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