Unhealthy Alcohol Drinking and Anesthetic Requirement in Women - Full Text View

Sponsor:	Nanjing Medical University
Information provided by:	Nanjing Medical University
ClinicalTrials.gov Identifier:	NCT00741507

Purpose

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.

Condition	Intervention
General Anesthesia	Behavioral: Alcohol drinking

Study Type:	Interventional
Study Design:	Screening, Non-Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety Study
Official Title:	Unhealthy Alcohol Drinking and Anesthetic Requirement in General Anesthesia in Women

Resource links provided by NLM:

MedlinePlus related topics: Alcohol Anesthesia

Drug Information available for: Ethanol

U.S. FDA Resources

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:

Anesthetic requirements [ Time Frame: 10 min after completion of operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Economic assessment [ Time Frame: 1 day after operation ] [ Designated as safety issue: No ]
Odds Ratio of alcohol use and the consumption of anesthetics [ Time Frame: 1 day after completion of study ] [ Designated as safety issue: No ]
Side effects [ Time Frame: 30 min after completion of the study ] [ Designated as safety issue: Yes ]
Bispectral Index (BIS) value [ Time Frame: 0, 5, 10, 20, 30, 45, 60, 90 min after anesthesia ] [ Designated as safety issue: Yes ]

Enrollment:	200
Study Start Date:	September 2008
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator No alcohol drinking	Behavioral: Alcohol drinking Never drinking of alcohol
2: Active Comparator Mild alcohol drinking	Behavioral: Alcohol drinking Mild drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
3: Active Comparator Moderate alcohol drinking	Behavioral: Alcohol drinking Moderate drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
4: Active Comparator Severe over alcohol drinking	Behavioral: Alcohol drinking Severe over drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
5: Active Comparator Alcohol-dependent	Behavioral: Alcohol drinking Alcohol-dependent assessed by "alcohol use disorders identification test (AUDIT)"

Eligibility

Ages Eligible for Study:	19 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741507

Locations

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

Sponsors and Collaborators

Nanjing Medical University

Investigators

Study Chair:

XiaoFeng Shen, MD

Nanjing Medical University

More Information

No publications provided

Responsible Party:	Nanjing Medical University ( XiaoFeng Shen )
Study ID Numbers:	NMU-FY2008-329, NJFY-230MZ
Study First Received:	August 20, 2008
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00741507 History of Changes
Health Authority:	China: Ethics Committee

Keywords provided by Nanjing Medical University:

Anesthetics
Sedatives
Analgesics

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
Therapeutic Uses
Physiological Effects of Drugs
Drinking Behavior
Central Nervous System Depressants

Anesthetics
Alcohol Drinking
Central Nervous System Agents
Pharmacologic Actions
Ethanol

ClinicalTrials.gov processed this record on February 08, 2010