HypertensionPhase 2NCT03166228
Hemodynamic Changes During Operative Hysteroscopy
A Phase 2 study testing Normal Saline 0.9% Infusion Solution Bag and 1.5% Glycine only in people with Hypertension, run by Assiut University at 1 site in Egypt.
Trial summary
Hysteroscopy is a minimally invasive gynaecological procedure in which an endoscopic optical lens is inserted through the cervix into the endometrial cavity to assists in the diagnosis of a vast number of uterine pathologies Historically, urologists used the resectoscope to perform a transurethral prostatectomy. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Normal Saline 0.9% Infusion Solution Bag and 1.5% Glycine only
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2018to 17 Jun 2022
- Phase
- Phase 2
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- In this study we will include 60 patients (age ranged from 20 to 40 years) with uterine size less than 12 weeks and cavity depth less than 12cm. Different types of intrauterine lesions (submucous fibroids of types 0, 1 and 2 with diameter less than 4 cm, polyps,septum and adhesions).
Who cannot join
- Any case with the following diseases will be excluded from the study.
- Cardiac diseases (myocardial ischemia, myocardial infarction or valve lesions).
- Renal impairment.
- Neurological affection.
- Chest diseases.
- Hepatic impairment.
- coagulation abnormalities.
- Patient refusal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hematological, Biochemical and Hemodynamic Changes During Operative Hysteroscopy Using Consecutive Distension Media
Hysteroscopy is a minimally invasive gynaecological procedure in which an endoscopic optical lens is inserted through the cervix into the endometrial cavity to assists in the diagnosis of a vast number of uterine pathologies Historically, urologists used the resectoscope to perform a transurethral prostatectomy. This instrument was later modified to accommodate gynaecological applications. Operative hysteroscopy became popular after improvements in endoscopic technology and instruments in the 1970s and after the introduction of fluid distension media in the 1980s (1). During the past 2 decades, hysteroscopy has been increasingly used for operative procedures
Read the detailed description
Operative hysteroscopy has become a standard surgical treatment for abnormal uterine bleeding unresponsive to conservative medical management since it was shown as a safe and effective alternative to hysterectomy.(2,3) Monopolar resectoscope necessitates an irrigating fluid that should be a non-conductive and salt free solution such as glycine 1.5% or sorbitol 3%.(4) Physiologic irrigating fluids (e.g. saline 0.9%) are contraindicated with these instruments since electric current generated by any monopolar electro surgical unit is preferentially conducted through low impedance fluid rather than through tissue and consequently it's difficult to initiate cutting and impossible to create significant tissue coagulation with these devices The clinical drawback of non-conductive irrigating solution (e.g. glycine 1.5%) is the risk of excessive fluid absorption leading to symptomatic dilutional hyponatremia and for hypotonic solutions, hypo-osmolarity and secondary cerebral oedema as Glycine is metabolized to carbon dioxide, water and ammonia, and may lead to intra-cellular over hydration and neurotoxicity which is clinically reflected as hypoxemia, agitation, nausea and hypertension.(5).Although rare, irreversible neurologic damage and death have been reported after excessive absorption of salt free irrigating solutions during routine operative hysteroscopy(6)Theoretically, distension with 0.9% saline as a distension medium avoids most of the above mentioned risks associated with hyper absorption of non electrolytic distension media(7) However, there is no doubt that excessive absorption of normal saline can be fatal(8).
Recently , it has been suggested that the type of anesthesia could modify fluid absorption(9). General anaesthesia has been associated with less Glycine absorption than epidural anaesthesia: the latter being associated with systemic vasodilatation(9).
- Conditions
- Hypertension
- Being tested
- Normal Saline 0.9% Infusion Solution Bag, 1.5% Glycine only
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Saline 0.9% Infusion Solution BagDrug
0.9% saline as distension medium as long as diathermy is not in use
1.5% Glycine onlyDrug
1.5% Glycine alone during hysteroscopy as long as diathermy is in use
| Study group | Role | What they receive |
|---|---|---|
| normal saline0.9% | Active comparator | 0.9% saline distension media is used as long as diathermy is not in use Receives: Drug: Normal Saline 0.9% Infusion Solution Bag |
| 1.5% GLYCINE | Placebo comparator | 1.5% GLYCINE DURING OPERATIVE HYSTEROSCOPY as long as diathermy is in use Receives: Drug: 1.5% Glycine only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Systolic Blood Pressure
Non-invasive blood pressure measurement by using sphygmomanometer cuff
Measured: data will be collected over 24 hours from the beginning of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start5 Jan 2018
- Primary completion17 Jun 2022
- Study completion17 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Assiut 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed sonbaty, Assiut University
- Investigators
- AHMED sonbaty, doctor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166228
- Sponsor's protocol ID
- ahmed 2017
- Status last verified
- Jul 2022
- First submitted
- 13 May 2017
- Last updated
- 6 Jul 2022
- 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 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematological, Biochemical and Hemodynamic Changes During Operative Hysteroscopy Using Consecutive Distension Media
- ClinicalTrials.gov ID
- NCT03166228
- Acronym / sponsor ID
- ahmed 2017
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 25 May 2017 (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.
Hysteroscopy is a minimally invasive gynaecological procedure in which an endoscopic optical lens is inserted through the cervix into the endometrial cavity to assists in the diagnosis of a vast number of uterine pathologies Historically, urologists used the resectoscope to perform a transurethral prostatectomy. This instrument was later modified to accommodate gynaecological applications. Operative hysteroscopy became popular after improvements in endoscopic technology and instruments in the 1970s and after the introduction of fluid distension media in the 1980s (1). During the past 2 decades, hysteroscopy has been increasingly used for operative procedures
Detailed description
Operative hysteroscopy has become a standard surgical treatment for abnormal uterine bleeding unresponsive to conservative medical management since it was shown as a safe and effective alternative to hysterectomy.(2,3) Monopolar resectoscope necessitates an irrigating fluid that should be a non-conductive and salt free solution such as glycine 1.5% or sorbitol 3%.(4) Physiologic irrigating fluids (e.g. saline 0.9%) are contraindicated with these instruments since electric current generated by any monopolar electro surgical unit is preferentially conducted through low impedance fluid rather than through tissue and consequently it's difficult to initiate cutting and impossible to create significant tissue coagulation with these devices The clinical drawback of non-conductive irrigating solution (e.g. glycine 1.5%) is the risk of excessive fluid absorption leading to symptomatic dilutional hyponatremia and for hypotonic solutions, hypo-osmolarity and secondary cerebral oedema as Glycine is metabolized to carbon dioxide, water and ammonia, and may lead to intra-cellular over hydration and neurotoxicity which is clinically reflected as hypoxemia, agitation, nausea and hypertension.(5).Although rare, irreversible neurologic damage and death have been reported after excessive absorption of salt free irrigating solutions during routine operative hysteroscopy(6)Theoretically, distension with 0.9% saline as a distension medium avoids most of the above mentioned risks associated with hyper absorption of non electrolytic distension media(7) However, there is no doubt that excessive absorption of normal saline can be fatal(8).
Recently , it has been suggested that the type of anesthesia could modify fluid absorption(9). General anaesthesia has been associated with less Glycine absorption than epidural anaesthesia: the latter being associated with systemic vasodilatation(9).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal saline0.9% | Active comparator | Drug: Normal Saline 0.9% Infusion Solution Bag0.9% saline distension media is used as long as diathermy is not in use |
| 1.5% GLYCINE | Placebo comparator | Drug: 1.5% Glycine only1.5% GLYCINE DURING OPERATIVE HYSTEROSCOPY as long as diathermy is in use |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- In this study we will include 60 patients (age ranged from 20 to 40 years) with uterine size less than 12 weeks and cavity depth less than 12cm. Different types of intrauterine lesions (submucous fibroids of types 0, 1 and 2 with diameter less than 4 cm, polyps,septum and adhesions).
Key exclusion criteria (8 listed)
- Any case with the following diseases will be excluded from the study.
- Cardiac diseases (myocardial ischemia, myocardial infarction or valve lesions).
- Renal impairment.
- Neurological affection.
- Chest diseases.
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 |
|---|---|---|
| Normal Saline 0.9% Infusion Solution Bag0.9% saline as distension medium as long as diathermy is not in use | Drug | normal saline0.9% |
| 1.5% Glycine only1.5% Glycine alone during hysteroscopy as long as diathermy is in use | Drug | 1.5% GLYCINE |
Primary outcome
Change from Baseline Systolic Blood Pressure
Time frame: data will be collected over 24 hours from the beginning of the procedure
Non-invasive blood pressure measurement by using sphygmomanometer cuff
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 6 Jul 2022.
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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.
AHMED sonbaty, doctor principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Normal Saline 0.9% Infusion Solution Bag and 1.5% Glycine only in people with Hypertension, run by Assiut University at 1 site in Egypt.
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 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 6 Jul 2022. 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 Egypt. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from Baseline Systolic Blood Pressure (time frame: data will be collected over 24 hours from the beginning of the procedure). 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 6 Jul 2022.