Text Size

Unhealthy Alcohol Drinking and Anesthetic Requirement in Women (UNADAREW)

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00741507
First received: August 20, 2008
Last updated: July 14, 2009
Last verified: July 2009
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Unhealthy Alcohol Drinking and Anesthetic Requirement in General Anesthesia in Women

Resource links provided by NLM:

MedlinePlus related topics: Alcohol
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
Active Comparator: 1
No alcohol drinking
 Behavioral: Alcohol drinking
Never drinking of alcohol
Other Name: Ethanol use
Active Comparator: 2
Mild alcohol drinking
 Behavioral: Alcohol drinking
Mild drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Other Name: Ethanol use
Active Comparator: 3
Moderate alcohol drinking
 Behavioral: Alcohol drinking
Moderate drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Other Name: Ethanol use
Active Comparator: 4
Severe over alcohol drinking
 Behavioral: Alcohol drinking
Severe over drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Other Name: Ethanol use
Active Comparator: 5
Alcohol-dependent
 Behavioral: Alcohol drinking
Alcohol-dependent assessed by "alcohol use disorders identification test (AUDIT)"
Other Name: Ethanol use

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

Keywords provided by Nanjing Medical University:
Anesthetics
Sedatives
Analgesics

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Ethanol
Anesthetics
Anti-Infective Agents, Local
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013