General AnesthesiaUNADAREWNCT00741507
Unhealthy Alcohol Drinking and Anesthetic Requirement in Women
A study testing Alcohol drinking in people with General Anesthesia, run by Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Alcohol drinking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Sep 2008to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I-II
- Chinese
- 19-45yr
- Undergoing general anesthesia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
Official title: Unhealthy Alcohol Drinking and Anesthetic Requirement in General Anesthesia in Women
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.
- Conditions
- General Anesthesia
- Being tested
- Alcohol drinking
- Keywords
- Anesthetics, Sedatives, Analgesics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol drinkingBehavioural
Also called Ethanol use
Never drinking of alcohol
Alcohol drinkingBehavioural
Also called Ethanol use
Mild drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Alcohol drinkingBehavioural
Also called Ethanol use
Moderate drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Alcohol drinkingBehavioural
Also called Ethanol use
Severe over drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"
Alcohol drinkingBehavioural
Also called Ethanol use
Alcohol-dependent assessed by "alcohol use disorders identification test (AUDIT)"
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | No alcohol drinking Receives: Behavioral: Alcohol drinking |
| 2 | Active comparator | Mild alcohol drinking Receives: Behavioral: Alcohol drinking |
| 3 | Active comparator | Moderate alcohol drinking Receives: Behavioral: Alcohol drinking |
| 4 | Active comparator | Severe over alcohol drinking Receives: Behavioral: Alcohol drinking |
| 5 | Active comparator | Alcohol-dependent Receives: Behavioral: Alcohol drinking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthetic requirements
Measured: 10 min after completion of operation
Secondary outcomes (4)
Economic assessment
Measured: 1 day after operation
Odds Ratio of alcohol use and the consumption of anesthetics
Measured: 1 day after completion of study
Side effects
Measured: 30 min after completion of the study
Bispectral Index (BIS) value
Measured: 0, 5, 10, 20, 30, 45, 60, 90 min after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- XiaoFeng Shen, MD, Study chair, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741507
- Sponsor's protocol ID
- NMU-FY2008-329
- Other IDs
- NJFY-230MZ
- Acronym
- UNADAREW
- Status last verified
- Jul 2009
- First submitted
- 20 Aug 2008
- Last updated
- 15 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unhealthy Alcohol Drinking and Anesthetic Requirement in General Anesthesia in Women
- ClinicalTrials.gov ID
- NCT00741507
- Acronym / sponsor ID
- UNADAREW / NMU-FY2008-329
- Conditions
- General Anesthesia
- Keywords
- Anesthetics, Sedatives, Analgesics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 26 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Alcohol drinkingNo alcohol drinking |
| 2 | Active comparator | Behavioral: Alcohol drinkingMild alcohol drinking |
| 3 | Active comparator | Behavioral: Alcohol drinkingModerate alcohol drinking |
| 4 | Active comparator | Behavioral: Alcohol drinkingSevere over alcohol drinking |
| 5 | Active comparator | Behavioral: Alcohol drinkingAlcohol-dependent |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA physical status I-II
- Chinese
- 19-45yr
- Undergoing general anesthesia
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol drinkingAlso: Ethanol useNever drinking of alcohol | Behavioural | 1 |
| Alcohol drinkingAlso: Ethanol useMild drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)" | Behavioural | 2 |
| Alcohol drinkingAlso: Ethanol useModerate drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)" | Behavioural | 3 |
| Alcohol drinkingAlso: Ethanol useSevere over drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)" | Behavioural | 4 |
| Alcohol drinkingAlso: Ethanol useAlcohol-dependent assessed by "alcohol use disorders identification test (AUDIT)" | Behavioural | 5 |
Primary outcome
Anesthetic requirements
Time frame: 10 min after completion of operation
4 secondary outcomes
Economic assessment
Time frame: 1 day after operation
Odds Ratio of alcohol use and the consumption of anesthetics
Time frame: 1 day after completion of study
Side effects
Time frame: 30 min after completion of the study
Bispectral Index (BIS) value
Time frame: 0, 5, 10, 20, 30, 45, 60, 90 min after anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XiaoFeng Shen, MD study chair
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol drinking in people with General Anesthesia, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthetic requirements (time frame: 10 min after completion of operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2009.