OxytocinNCT04109339
Effects of Oxytocin on Hemodynamics in Patients Undergoing Laparoscopic Myomectomy
A study testing Oxytocin in people with Oxytocin and Hemodynamic Monitoring, run by Yangzhou University at 1 site in China.
Trial summary
This project will study the effect of oxytocin on hemodynamics in patients undergoing laparoscopic myomectomy, and how to prevent and manage such hemodynamic changes effectively.It provides a reference for the rational use of oxytocin in clinical practice, which can not only effectively contract the uterus and reduce… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oxytocin, Hemodynamic Monitoring, Laparoscopic Surgery
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 1 Oct 2020
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General anesthesia for gynecological laparoscopic surgery,ASA I~III
Who cannot join
- Oxytocin use contraindications
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu, 225012
Zhuan Zhang, +8615062791355 ext. +8615062791355, zhangzhuanjy@163.com
About this study
This project will study the effect of oxytocin on hemodynamics in patients undergoing laparoscopic myomectomy, and how to prevent and manage such hemodynamic changes effectively.It provides a reference for the rational use of oxytocin in clinical practice, which can not only effectively contract the uterus and reduce bleeding, but also reduce the influence on hemodynamics.
- Conditions
- Oxytocin, Hemodynamic Monitoring, Laparoscopic Surgery
- Being tested
- Oxytocin
- Keywords
- Oxytocin, Hemodynamic, Myomectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
During the laparoscopic hysteromyomectomia operation, different doses of oxytocin was used with different routs.
| Study group | Role | What they receive |
|---|---|---|
| group 1 with no oxytocin | No intervention | Not described |
| group 2 with oxytocin 10 U IM + oxytocin 10 U IV | Experimental | Not described Receives: Drug: Oxytocin |
| group 3 with oxytocin 20 U IM + oxytocin 0 U IV | Experimental | Not described Receives: Drug: Oxytocin |
| group 4 with oxytocin 0 U IM + oxytocin 20 U IV | Experimental | Not described Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of traditional hemodynamic parameters after oxytocin use during laparoscopic hysteromyomectomia.
Parameters including SBP, DBP, MAP (mmHg) were measured by a Mostcare hemodynamic monitor.
Measured: "before induction", "before incision", "before oxytocin intramuscular injection", and "20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection".
Changes of traditional hemodynamic parameters after oxytocin use during laparoscopic hysteromyomectomia.
HR (beats/min) was measured by a Mostcare hemodynamic monitor.
Measured: "before induction", "before incision", "before oxytocin intramuscular injection", and "20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection".
Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia.
SVV (%) was measured by a Mostcare hemodynamic monitor.
Measured: "before induction", "before incision", "before oxytocin intramuscular injection", and "20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection".
Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia.
SVRI (dynes-sec/cm-5) was measured by a Mostcare hemodynamic monitor.
Measured: "before induction", "before incision", "before oxytocin intramuscular injection", and "20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection".
Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia.
CI (l/min/m2) was measured by a Mostcare hemodynamic monitor.
Measured: "before induction", "before incision", "before oxytocin intramuscular injection", and "20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection".
Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia.
CO (l/min) was measured by a Mostcare hemodynamic monitor.
Measured: "before induction", "before incision", "before oxytocin intramuscular injection", and "20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 May 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OxytocinStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yangzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Zhang, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109339
- Sponsor's protocol ID
- 20190501
- Status last verified
- Sep 2019
- First submitted
- 15 Aug 2019
- Last updated
- 30 Sep 2019
- 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 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oxytocin on Hemodynamics in Patients Undergoing Laparoscopic Myomectomy
- ClinicalTrials.gov ID
- NCT04109339
- Acronym / sponsor ID
- 20190501
- Conditions
- Oxytocin, Hemodynamic Monitoring, Laparoscopic Surgery
- Keywords
- Oxytocin, Hemodynamic, Myomectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Yangzhou UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 30 Sep 2019 (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 project will study the effect of oxytocin on hemodynamics in patients undergoing laparoscopic myomectomy, and how to prevent and manage such hemodynamic changes effectively.It provides a reference for the rational use of oxytocin in clinical practice, which can not only effectively contract the uterus and reduce bleeding, but also reduce the influence on hemodynamics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1 with no oxytocin | No intervention | – |
| group 2 with oxytocin 10 U IM + oxytocin 10 U IV | Experimental | Drug: Oxytocin |
| group 3 with oxytocin 20 U IM + oxytocin 0 U IV | Experimental | Drug: Oxytocin |
| group 4 with oxytocin 0 U IM + oxytocin 20 U IV | Experimental | Drug: Oxytocin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- General anesthesia for gynecological laparoscopic surgery,ASA I~III
Key exclusion criteria (1 listed)
- Oxytocin use contraindications
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 |
|---|---|---|
| OxytocinDuring the laparoscopic hysteromyomectomia operation, different doses of oxytocin was used with different routs. | Drug | group 2 with oxytocin 10 U IM + oxytocin 10 U IV, group 3 with oxytocin 20 U IM + oxytocin 0 U IV, group 4 with oxytocin 0 U IM + oxytocin 20 U IV |
Primary outcome
Changes of traditional hemodynamic parameters after oxytocin use during laparoscopic hysteromyomectomia.
Time frame: "before induction", "before incision", "before oxytocin intramuscular injection", and "20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection".
Parameters including SBP, DBP, MAP (mmHg) were measured by a Mostcare hemodynamic monitor.
Changes of traditional hemodynamic parameters after oxytocin use during laparoscopic hysteromyomectomia.
Time frame: "before induction", "before incision", "before oxytocin intramuscular injection", and "20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection".
HR (beats/min) was measured by a Mostcare hemodynamic monitor.
Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia.
Time frame: "before induction", "before incision", "before oxytocin intramuscular injection", and "20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection".
SVV (%) was measured by a Mostcare hemodynamic monitor.
Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia.
Time frame: "before induction", "before incision", "before oxytocin intramuscular injection", and "20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection".
SVRI (dynes-sec/cm-5) was measured by a Mostcare hemodynamic monitor.
Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia.
Time frame: "before induction", "before incision", "before oxytocin intramuscular injection", and "20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection".
CI (l/min/m2) was measured by a Mostcare hemodynamic monitor.
Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia.
Time frame: "before induction", "before incision", "before oxytocin intramuscular injection", and "20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection".
CO (l/min) was measured by a Mostcare hemodynamic monitor.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Oxytocin and Hemodynamic Monitoring, run by Yangzhou 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 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 30 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhuan Zhang (+8615062791355 ext. +8615062791355, zhangzhuanjy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of traditional hemodynamic parameters after oxytocin use during laparoscopic hysteromyomectomia. (time frame: "before induction", "before incision", "before oxytocin intramuscular injection", and "20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection".). The study lists 6 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 2019.