Unhealthy Alcohol Drinking and Anesthetic Requirement in Women

General Anesthesia Clinical Trial

— UNADAREW  

Official title:

Unhealthy Alcohol Drinking and Anesthetic Requirement in General Anesthesia in Women

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

• Alcohol Drinking
• General Anesthesia

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