Fluid OverloadNCT04328870
Fluid Absorption in Patients Undergoing Operative Hysteroscopy; Results From a Prospective Controlled Study
A study testing oxytocin and spinal anesthesia and General anesthsia in people with Fluid Overload, run by University of Jordan at 1 site in Jordan.
Trial summary
To determine if combining intravenous oxytocin infusion and spinal anesthesia will reduce the amount of glycine absorption in patients undergoing operative hysteroscopy Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Fluid Overload
- What is being tested?
- oxytocin and spinal anesthesia and General anesthsia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteJordan
- Study dates
- 20 May 2018to 30 Sep 2019
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- premenopausal with no cardiovascular comorbidities
Who cannot join
- endometrial cancer cases, patients who received pre-operative hormonal preparations, previously resected cases and cases done using bipolar diathermy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Spinal Anesthesia and Use of Oxytocin on Fluid Absorption in Patients Undergoing Operative Hysteroscopy; Results From a Prospective Controlled Study
To determine if combining intravenous oxytocin infusion and spinal anesthesia will reduce the amount of glycine absorption in patients undergoing operative hysteroscopy
Read the detailed description
Prospective controlled study in premenopausal patients who had hysteroscopic surgery including endometrial resection, endometrial polypectomy, myomectomy resection and uterine septal resection. The effect of combined spinal anesthetic with oxytocin infusion on fluid deficit was studied.
- Conditions
- Fluid Overload
- Being tested
- oxytocin and spinal anesthesia, General anesthsia
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytocin and spinal anesthesiaOther
start oxytocin 10 IU/200 ml saline at the insertion of the spinal anesthesia
General anesthsiaOther
General anesthesia alone.
| Study group | Role | What they receive |
|---|---|---|
| oxytocin and spinal anesthesia | Active comparator | spinal anesthesia combined with intravenous oxytocin infusion Receives: Other: oxytocin and spinal anesthesia |
| general anesthsia | Active comparator | general anesthesia alone Receives: Other: General anesthsia |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid overload
Fluid (glycine) excessive absorption into the patient
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start20 May 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid OverloadStudies 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naser Al-Husban, University of Jordan
- Investigators
- Abdelkarim ALoweidi, consultant, Study director, jordan university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328870
- Sponsor's protocol ID
- IORG0007981
- Status last verified
- Mar 2020
- First submitted
- 25 Mar 2020
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Spinal Anesthesia and Use of Oxytocin on Fluid Absorption in Patients Undergoing Operative Hysteroscopy; Results From a Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT04328870
- Acronym / sponsor ID
- IORG0007981
- Conditions
- Fluid Overload
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 20 May 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 31 Mar 2020 (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.
To determine if combining intravenous oxytocin infusion and spinal anesthesia will reduce the amount of glycine absorption in patients undergoing operative hysteroscopy
Detailed description
Prospective controlled study in premenopausal patients who had hysteroscopic surgery including endometrial resection, endometrial polypectomy, myomectomy resection and uterine septal resection. The effect of combined spinal anesthetic with oxytocin infusion on fluid deficit was studied.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin and spinal anesthesia | Active comparator | Other: oxytocin and spinal anesthesiaspinal anesthesia combined with intravenous oxytocin infusion |
| general anesthsia | Active comparator | Other: General anesthsiageneral anesthesia alone |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- premenopausal with no cardiovascular comorbidities
Key exclusion criteria (1 listed)
- endometrial cancer cases, patients who received pre-operative hormonal preparations, previously resected cases and cases done using bipolar diathermy.
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 |
|---|---|---|
| oxytocin and spinal anesthesiastart oxytocin 10 IU/200 ml saline at the insertion of the spinal anesthesia | Other | oxytocin and spinal anesthesia |
| General anesthsiaGeneral anesthesia alone. | Other | general anesthsia |
Primary outcome
fluid overload
Time frame: 16 months
Fluid (glycine) excessive absorption into the patient
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 31 Mar 2020.
- Individual participant dataSharing planned: Yes. on reasonable request
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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.
Abdelkarim ALoweidi, consultant study director
jordan 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 oxytocin and spinal anesthesia and General anesthsia in people with Fluid Overload, run by University of Jordan at 1 site in Jordan.
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: finished, as of the sponsor's last update on 31 Mar 2020. 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 Jordan. 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?
fluid overload (time frame: 16 months). 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 31 Mar 2020.