General Anesthesia Clinical Trial
— UNADAREWOfficial title:
Unhealthy Alcohol Drinking and Anesthetic Requirement in General Anesthesia in Women
Verified date | July 2009 |
Source | Nanjing Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Interventional |
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.
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening
Country | Name | City | State |
---|---|---|---|
China | Nanjing Maternal and Child Health Care Hospital | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Nanjing Medical University |
China,
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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