HysteromyomaPhase 3NCT03524950
Effect of Dexmedetomidine on Stress Study of Pituitrin in Laparoscopic Hysteromyoma Surgery
A Phase 3 study testing Dexmedetomidine in people with Hysteromyoma, run by Beijing Anzhen Hospital.
Trial summary
This study is about the effect of dexmedetomidine to the stress of pituitrin in laparoscopic hysteromyoma surgery. It is well known that pituitrin has been widespread used in the laparoscopic hysteromyoma surgery. Pituitrin includes oxytocin and vasopressin. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysteromyoma
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2018to 31 Dec 2019
- Phase
- Phase 3
- 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 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Surgery will be scheduled as first case in the morning at 9 Am. On arrival to the operation room, intravenous access will be achieved with venous cannula under local anesthesia with 2% lidocaine. Monitoring consisted of 5 lead electrocardiography, pulse oximeter, noninvasive blood pressure, end tidal carbon dioxide, and bispectral index.
Who cannot join
- Diabetic,chronic hypertension,patients on drugs such as beta blockers or calcium channel blockers,pregnant or lactating women, patients with abnormal serum creatinine and blood urea nitrogen, and patients with a history of allergy to drugs particularly α2 agonists.
Trial locations and contacts
No sites are listed yet.
About this study
This study is about the effect of dexmedetomidine to the stress of pituitrin in laparoscopic hysteromyoma surgery. It is well known that pituitrin has been widespread used in the laparoscopic hysteromyoma surgery. Pituitrin includes oxytocin and vasopressin. Vasopressin increase body stress reaction through hypothalamic pituitary adrenal(HPA) axis. The HPA axis has has main role to the body stress reaction. Dexmedetomidine can inhibit the stress responses mediated by the sympathetic nervous system. Therefore,the effect of dexmedetomidine to the stress of pituitrin in laparoscopic hysteromyoma surgery is worth to be studied.
- Conditions
- Hysteromyoma
- Being tested
- Dexmedetomidine
- Keywords
- stress, dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Ninety patients will be assigned to three groups. Group A add saline in general anesthesia laparoscopic hysteromyoma surgery. Group B add dexmedetomidine 1μg/Kg10minutes as loading dose, followed by 0.7μg/Kg/h for maintenance.Group C add dexmedetomidine 0.7μg/Kg10minutes as loading dose, followed by 0.5μg/Kg/h for maintenance.
| Study group | Role | What they receive |
|---|---|---|
| no dexmedetomidine | No intervention | Not described |
| high dose dexmedetomidine | Experimental | Not described Receives: Drug: Dexmedetomidine |
| low dose dexmedetomidine | Experimental | Not described Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
acth
adrenocorticotropic hormone
Measured: the acth before using pituitrin 5 minutes
acth
adrenocorticotropic hormone
Measured: the acth after using pituitrin 20 minutes
acth
adrenocorticotropic hormone
Measured: the acth after using pituitrin 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start1 Jun 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysteromyomaStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xia CAO, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524950
- Sponsor's protocol ID
- D to stress study of pituitrin
- Status last verified
- May 2018
- First submitted
- 2 May 2018
- Last updated
- 15 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on Stress Study of Pituitrin in Laparoscopic Hysteromyoma Surgery
- ClinicalTrials.gov ID
- NCT03524950
- Acronym / sponsor ID
- D to stress study of pituitrin
- Conditions
- Hysteromyoma
- Keywords
- stress, dexmedetomidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 15 May 2018 (actual)
- 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.
This study is about the effect of dexmedetomidine to the stress of pituitrin in laparoscopic hysteromyoma surgery. It is well known that pituitrin has been widespread used in the laparoscopic hysteromyoma surgery. Pituitrin includes oxytocin and vasopressin. Vasopressin increase body stress reaction through hypothalamic pituitary adrenal(HPA) axis. The HPA axis has has main role to the body stress reaction. Dexmedetomidine can inhibit the stress responses mediated by the sympathetic nervous system. Therefore,the effect of dexmedetomidine to the stress of pituitrin in laparoscopic hysteromyoma surgery is worth to be studied.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no dexmedetomidine | No intervention | – |
| high dose dexmedetomidine | Experimental | Drug: Dexmedetomidine |
| low dose dexmedetomidine | Experimental | Drug: Dexmedetomidine |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Surgery will be scheduled as first case in the morning at 9 Am. On arrival to the operation room, intravenous access will be achieved with venous cannula under local anesthesia with 2% lidocaine. Monitoring consisted of 5 lead electrocardiography, pulse oximeter, noninvasive blood pressure, end tidal carbon dioxide, and bispectral index.
Key exclusion criteria (1 listed)
- Diabetic,chronic hypertension,patients on drugs such as beta blockers or calcium channel blockers,pregnant or lactating women, patients with abnormal serum creatinine and blood urea nitrogen, and patients with a history of allergy to drugs particularly α2 agonists.
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 |
|---|---|---|
| DexmedetomidineNinety patients will be assigned to three groups. Group A add saline in general anesthesia laparoscopic hysteromyoma surgery. Group B add dexmedetomidine 1μg/Kg10minutes as loading dose, followed by 0.7μg/Kg/h for maintenance.Group C add dexmedetomidine 0.7μg/Kg10minutes as loading dose, followed by 0.5μg/Kg/h for maintenance. | Drug | high dose dexmedetomidine, low dose dexmedetomidine |
Primary outcome
acth
Time frame: the acth before using pituitrin 5 minutes
adrenocorticotropic hormone
acth
Time frame: the acth after using pituitrin 20 minutes
adrenocorticotropic hormone
acth
Time frame: the acth after using pituitrin 120 minutes
adrenocorticotropic hormone
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine in people with Hysteromyoma, run by Beijing Anzhen Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 May 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xia Cao, M.D.Candidate (+86-13811239739, 13811239739@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acth (time frame: the acth before using pituitrin 5 minutes). The study lists 3 primary outcomes in all. 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 May 2018.