Abnormal Menstrual CyclePhase 4NCT02035930
Effect of Dexmedetomidine on Bispectral Index and Propofol Requirements During Different Menstrual Cycle
A Phase 4 study testing dexmedetomidine in people with Abnormal Menstrual Cycle, run by Fudan University.
Trial summary
The study was done to evaluate the effects of the follicular and luteal phases of the menstrual cycle on sedation level at loss of consciousness and bispectral index reach to 50 during propofol anesthesia, in patients with and without preoperative intravenous dexmedetomidine . Read more about this study
- Who is it for?
- Ages 24 to 40 years, women only
- Conditions the study is for
- Abnormal Menstrual Cycle
- What is being tested?
- dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Nov 2012
- Phase
- Phase 4
- 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 24 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- a regular menstrual cycle
- elective gynecologic surgery
Who cannot join
- pregnancy
- breastfeeding
- obesity
- known hypersensitivity to drugs used in the study protocol;
- use of psychotropic drugs and steroids within 72 hours before the surgery
- central nervous system injury
- renal impairment
- alcoholism and opioid addiction.
About this study
The study was done to evaluate the effects of the follicular and luteal phases of the menstrual cycle on sedation level at loss of consciousness and bispectral index reach to 50 during propofol anesthesia, in patients with and without preoperative intravenous dexmedetomidine .
- Conditions
- Abnormal Menstrual Cycle
- Being tested
- dexmedetomidine
- Keywords
- Bispectral Index Monitor, Menstrual Cycle, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
| Study group | Role | What they receive |
|---|---|---|
| menstrual cycle,dexmedetomidine | Other | Not described Receives: Drug: dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
bispectral index at loss of eyelash reflex
Measured: up to 2 years
Secondary outcomes (1)
propofol requirements from propofol administered to loss of eyelash reflex and bispectral index reduced to 50
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startNov 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Menstrual CycleStudies of the same condition, open and under way.
- More trials run by Fudan 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geng guiqi, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035930
- Sponsor's protocol ID
- TWang
- Status last verified
- Jan 2014
- First submitted
- 10 Jan 2014
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on Bispectral Index and Propofol Requirements During Different Menstrual Cycle
- ClinicalTrials.gov ID
- NCT02035930
- Acronym / sponsor ID
- TWang
- Conditions
- Abnormal Menstrual Cycle
- Keywords
- Bispectral Index Monitor, Menstrual Cycle, Dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 14 Jan 2014 (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.
The study was done to evaluate the effects of the follicular and luteal phases of the menstrual cycle on sedation level at loss of consciousness and bispectral index reach to 50 during propofol anesthesia, in patients with and without preoperative intravenous dexmedetomidine .
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| menstrual cycle,dexmedetomidine | Other | Drug: dexmedetomidine |
Who may qualify
- Ages
- 24 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- a regular menstrual cycle
- elective gynecologic surgery
Key exclusion criteria (8 listed)
- pregnancy
- breastfeeding
- obesity
- known hypersensitivity to drugs used in the study protocol;
- use of psychotropic drugs and steroids within 72 hours before the surgery
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 |
|---|---|---|
| dexmedetomidine | Drug | menstrual cycle,dexmedetomidine |
Primary outcome
bispectral index at loss of eyelash reflex
Time frame: up to 2 years
1 secondary outcome
propofol requirements from propofol administered to loss of eyelash reflex and bispectral index reduced to 50
Time frame: up to 2 years
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 14 Jan 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexmedetomidine in people with Abnormal Menstrual Cycle, run by Fudan University.
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 2 inclusion and 8 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 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
bispectral index at loss of eyelash reflex (time frame: up to 2 years). 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 14 Jan 2014.