Gynecological PatientPhase 4NCT02220361
Dexmedetomidine on Prevention of Side Effects of Hemabate
A Phase 4 study testing low dose dexmedetomidine and high dose dexmedetomidine in people with Gynecological Patient, run by Jin Ni.
Trial summary
Hemabate is often used for gynecological patients. Hemabate is associated with many side effects, including a burning sensation in the stomach, nausea, vomiting, diarrhea etc. It is reported that dexmedetomidine reduce gastrointestinal reaction during perioperative period. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecological Patient
- What is being tested?
- low dose dexmedetomidine and high dose dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Dec 2014
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- gynecological patients
Who cannot join
- Neuromuscular and endocrine diseases
- Allergic reactions to a2-adrenergic agonist
- Previous abdominal surgery including prior caesarean section.
About this study
Official title: Phase 4 Study of Effects of Dexmedetomidine on Prevention of Side Effects of Hemabate in Cesarean Section Patients
Hemabate is often used for gynecological patients. Hemabate is associated with many side effects, including a burning sensation in the stomach, nausea, vomiting, diarrhea etc. It is reported that dexmedetomidine reduce gastrointestinal reaction during perioperative period. We design this clinical trial to find if dexmedetomidine can prevent the side effects of hemabate in Cesarean Section patients.
- Conditions
- Gynecological Patient
- Being tested
- placebo, low dose dexmedetomidine, high dose dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
received 20 ml intravenous physiological saline The infusion were completed in 30 minutes.
low dose dexmedetomidineDrug
received 0.5μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline The infusion were completed in 30 minutes.
high dose dexmedetomidineDrug
received 1μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline.
The infusion was completed in 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| placebo group | Placebo comparator | received 20 ml intravenous physiological saline Receives: Drug: placebo |
| low dose dexmedetomidine group | Experimental | received 0.5μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline Receives: Drug: low dose dexmedetomidine |
| hemabate+high dose dexmedetomidine group | Experimental | received 1μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline Receives: Drug: high dose dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 Change
Measured: participants will be followed for the duration of surgery, an expected average of 2 hours
systolic blood pressure and diastolic blood pressure change
Measured: participants will be followed for the duration of surgery, an expected average of 2 hours
Heart rate change
Measured: participants will be followed for the duration of surgery, an expected average of 2 hours
nausea
Measured: 24 h postoperatively
vomiting
Measured: 24h postoperatively
fever
Measured: 24h postoperatively
diarrhea
Measured: 24h postoperatively
headache
Measured: 24h postoperatively
elevated blood pressure
Measured: 24h postoperatively
chest congestion
Measured: 24h postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological PatientStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jin Ni
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin Ni, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220361
- Sponsor's protocol ID
- JNi
- Other IDs
- DAGZWCMC
- Status last verified
- Sep 2014
- First submitted
- 14 Aug 2014
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Effects of Dexmedetomidine on Prevention of Side Effects of Hemabate in Cesarean Section Patients
- ClinicalTrials.gov ID
- NCT02220361
- Acronym / sponsor ID
- JNi
- Conditions
- Gynecological Patient
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Jin NiUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 19 Aug 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.
Hemabate is often used for gynecological patients. Hemabate is associated with many side effects, including a burning sensation in the stomach, nausea, vomiting, diarrhea etc. It is reported that dexmedetomidine reduce gastrointestinal reaction during perioperative period. We design this clinical trial to find if dexmedetomidine can prevent the side effects of hemabate in Cesarean Section patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | Drug: placeboreceived 20 ml intravenous physiological saline |
| low dose dexmedetomidine group | Experimental | Drug: low dose dexmedetomidinereceived 0.5μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline |
| hemabate+high dose dexmedetomidine group | Experimental | Drug: high dose dexmedetomidinereceived 1μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- gynecological patients
Key exclusion criteria (3 listed)
- Neuromuscular and endocrine diseases
- Allergic reactions to a2-adrenergic agonist
- Previous abdominal surgery including prior caesarean section.
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 |
|---|---|---|
| placeboreceived 20 ml intravenous physiological saline The infusion were completed in 30 minutes. | Drug | placebo group |
| low dose dexmedetomidinereceived 0.5μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline The infusion were completed in 30 minutes. | Drug | low dose dexmedetomidine group |
| high dose dexmedetomidinereceived 1μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline. The infusion was completed in 30 minutes | Drug | hemabate+high dose dexmedetomidine group |
Primary outcome
SpO2 Change
Time frame: participants will be followed for the duration of surgery, an expected average of 2 hours
systolic blood pressure and diastolic blood pressure change
Time frame: participants will be followed for the duration of surgery, an expected average of 2 hours
Heart rate change
Time frame: participants will be followed for the duration of surgery, an expected average of 2 hours
nausea
Time frame: 24 h postoperatively
vomiting
Time frame: 24h postoperatively
fever
Time frame: 24h postoperatively
diarrhea
Time frame: 24h postoperatively
headache
Time frame: 24h postoperatively
elevated blood pressure
Time frame: 24h postoperatively
chest congestion
Time frame: 24h postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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 low dose dexmedetomidine and high dose dexmedetomidine in people with Gynecological Patient, run by Jin Ni.
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 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: status not confirmed, as of the sponsor's last update on 30 Sep 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
SpO2 Change (time frame: participants will be followed for the duration of surgery, an expected average of 2 hours). The study lists 10 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 30 Sep 2014.