Intracranial Pressure Control in Pre-eclampsiaPhase 1NCT05119101
Dexamedtomidine in Control of Intracranial Pressure in Preeclampsia
A Phase 1 study testing Dexamedotomidine added to Magnesium sulfate and Magnesium sulfate in people with Intracranial Pressure Control in Pre-eclampsia, run by Assiut University at 1 site in Egypt.
Trial summary
The present study is designed to evaluate the differences in the effect of Mg sulphate alone and dexmedetomidine as an adjuvant to Mg sulphate on intracranial pressure when administered intravenously in cases of pre-eclampsia Read more about this study
- Who is it for?
- Ages 25 to 43 years, women only
- Conditions the study is for
- Intracranial Pressure Control in Pre-eclampsia
- What is being tested?
- Dexamedotomidine added to Magnesium sulfate and Magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to Dec 2023
- Phase
- Phase 1
- 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 25 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 25-43 and the gestational age above 34 weeks, with diagnostic preeclampsia (Hypertension and proteinuria) occurring after the 20th week of gestation and cesarian section is indicated with systolic blood pressure above 160 and diastolic blood pressure above 100.albumin in urine ++ or +++. No cardiac, hepatic,renal nor neurological problems.
Who cannot join
- Age: younger than 25 or older than 43.
- Pregnant females with mild preeclampsia.
- Patients with cerebro-vascular diseases, Glaucoma, Hepatic failure, Renal failure .
- patient who got their MgSO4 medication before the first reading of Optic nerve sheath diameter ONSD were also excluded.
- History of allergy to dexamedotomidine.
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine Assiut University
Asyut
Hossam Elden G Fakhry, DR, 01026269773 ext. 088, Dr.hossam.hg@gmail.com
About this study
Official title: Dexamedtomidine as Adjuvant to Magnesium Sulphate for Intracranial Pressure Control in Pre-eclampsia: a Randomized Controlled Trial.
The present study is designed to evaluate the differences in the effect of Mg sulphate alone and dexmedetomidine as an adjuvant to Mg sulphate on intracranial pressure when administered intravenously in cases of pre-eclampsia
Read the detailed description
Preeclampsia remains one of the leading causes of maternal morbidity and mortality in pregnant women. preeclampsia occurs in 7% to 8% of pregnancies. Preeclampsia is a multisystem progressive disorder characterized by the new onset of hypertension and proteinuria or the new onset of hypertension and significant end-organ dysfunction with or without proteinuria after 20 weeks of gestation or postpartum. Preeclampsia is a potentially severe disease associated with maternal complications. Cerebral oedema is predominantly vasogenic and may be related to failure of cerebral autoregulation with subsequent hyperperfusion, blood brain barrier disruption, and endothelial cell dysfunction.
The optic nerve with its dural sheath cover is considered a window to central nervous system. The subarachnoid space surrounds the optic nerve and communicates freely with the cerebral subarachnoid space. Changes in the optic nerve sheath diameter (ONSD) mirror the changes in the ICP as increases in the ONSD correlates with increase in the ICP.
Magnesium sulphate (MgSO4) is a drug that is routinely used in the treatment of preeclampsia and prevention of eclamptic fits. Currently, several mechanisms have been proposed by researchers to explain the neuroprotective effect of MgSO4 .Dexmedetomidine is a potent alpha-2 adrenergic receptor agonist. dexmedetomidine-induced stimulation of postsynaptic alpha-2 adrenergic receptor on the cerebral blood vessels can cause cerebral vasoconstriction and decrease cerebral blood flow.
- Being tested
- Dexamedotomidine added to Magnesium sulfate, Magnesium sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamedotomidine added to Magnesium sulfateDrug
Also called Precedex
we will give dexamedotomidine and mg sulphate and then measure intracranial pressure at different intervals by measuring Optic nerve sheath diameter (ONSD).
Magnesium sulfateDrug
Also called Mgso4
we will give mg sulphate and then measure intracranial pressure at different intervals by measuring Optic nerve sheath diameter (ONSD).
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulphate | Active comparator | patients will recieve Mg sulphate as loading dose of 4 g diluted in 200 ml normal saline intravenous over 10 minutes followed by 1 g/h infusion for 24 h. Receives: Drug: Magnesium sulfate |
| Dexamedotomidine adjuvant to Magnesium sulphate | Active comparator | Patients will reccieve Mg sulphate as loading dose of 4 g diluted in 200 ml normal saline intravenous over 10 minutes followed by 1 g/h infusion for 24 h. in addition they will receive an intravenous infusion of dexmedetomidine .5 μg/kg diluted in 200 ml normal saline intravenous over 10 minutes followed by .15 μg/kg/hr infusion for 24 h. Receives: Drug: Dexamedotomidine added to Magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
will be Optic nerve sheath diameter (ONSD) changes by using ultrasound as an indicator for changes in intracranial pressure in response to treatment with either mg sulphate alone or dexamedotomidine as an adjuvant to mg sulphate.
Measured: till two hours after cesarian section
Secondary outcomes (2)
o changes in levels of interleukin 6 (IL-6) in plasma before and after start of treatment in response to any change in brain activity
Measured: two hours after cesarian section
o The difference in umbilical blood flow indices by Doppler.
Measured: two hours after cesarian section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start1 Mar 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Pressure Control in Pre-eclampsiaStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Elden Gamal Fakhry, Assiut University
- Investigators
- HossamElden G Fakhry, DR, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119101
- Sponsor's protocol ID
- intracranial pressure control
- Status last verified
- Feb 2022
- First submitted
- 2 Nov 2021
- Last updated
- 22 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamedtomidine as Adjuvant to Magnesium Sulphate for Intracranial Pressure Control in Pre-eclampsia: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05119101
- Acronym / sponsor ID
- intracranial pressure control
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 12 Nov 2021 (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.
The present study is designed to evaluate the differences in the effect of Mg sulphate alone and dexmedetomidine as an adjuvant to Mg sulphate on intracranial pressure when administered intravenously in cases of pre-eclampsia
Detailed description
Preeclampsia remains one of the leading causes of maternal morbidity and mortality in pregnant women. preeclampsia occurs in 7% to 8% of pregnancies. Preeclampsia is a multisystem progressive disorder characterized by the new onset of hypertension and proteinuria or the new onset of hypertension and significant end-organ dysfunction with or without proteinuria after 20 weeks of gestation or postpartum. Preeclampsia is a potentially severe disease associated with maternal complications. Cerebral oedema is predominantly vasogenic and may be related to failure of cerebral autoregulation with subsequent hyperperfusion, blood brain barrier disruption, and endothelial cell dysfunction.
The optic nerve with its dural sheath cover is considered a window to central nervous system. The subarachnoid space surrounds the optic nerve and communicates freely with the cerebral subarachnoid space. Changes in the optic nerve sheath diameter (ONSD) mirror the changes in the ICP as increases in the ONSD correlates with increase in the ICP.
Magnesium sulphate (MgSO4) is a drug that is routinely used in the treatment of preeclampsia and prevention of eclamptic fits. Currently, several mechanisms have been proposed by researchers to explain the neuroprotective effect of MgSO4 .Dexmedetomidine is a potent alpha-2 adrenergic receptor agonist. dexmedetomidine-induced stimulation of postsynaptic alpha-2 adrenergic receptor on the cerebral blood vessels can cause cerebral vasoconstriction and decrease cerebral blood flow.
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 |
|---|---|---|
| Magnesium sulphate | Active comparator | Drug: Magnesium sulfatepatients will recieve Mg sulphate as loading dose of 4 g diluted in 200 ml normal saline intravenous over 10 minutes followed by 1 g/h infusion for 24 h. |
| Dexamedotomidine adjuvant to Magnesium sulphate | Active comparator | Drug: Dexamedotomidine added to Magnesium sulfatePatients will reccieve Mg sulphate as loading dose of 4 g diluted in 200 ml normal saline intravenous over 10 minutes followed by 1 g/h infusion for 24 h. in addition they will receive an intravenous infusion of dexmedetomidine .5 μg/kg diluted in 200 ml normal saline intravenous over 10 minutes followed by .15 μg/kg/hr infusion for 24 h. |
Who may qualify
- Ages
- 25 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female patients aged 25-43 and the gestational age above 34 weeks, with diagnostic preeclampsia (Hypertension and proteinuria) occurring after the 20th week of gestation and cesarian section is indicated with systolic blood pressure above 160 and diastolic blood pressure above 100.albumin in urine ++ or +++. No cardiac, hepatic,renal nor neurological problems.
Key exclusion criteria (6 listed)
- Age: younger than 25 or older than 43.
- Pregnant females with mild preeclampsia.
- Patients with cerebro-vascular diseases, Glaucoma, Hepatic failure, Renal failure .
- patient who got their MgSO4 medication before the first reading of Optic nerve sheath diameter ONSD were also excluded.
- History of allergy to dexamedotomidine.
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 |
|---|---|---|
| Dexamedotomidine added to Magnesium sulfateAlso: Precedexwe will give dexamedotomidine and mg sulphate and then measure intracranial pressure at different intervals by measuring Optic nerve sheath diameter (ONSD). | Drug | Dexamedotomidine adjuvant to Magnesium sulphate |
| Magnesium sulfateAlso: Mgso4we will give mg sulphate and then measure intracranial pressure at different intervals by measuring Optic nerve sheath diameter (ONSD). | Drug | Magnesium sulphate |
Primary outcome
will be Optic nerve sheath diameter (ONSD) changes by using ultrasound as an indicator for changes in intracranial pressure in response to treatment with either mg sulphate alone or dexamedotomidine as an adjuvant to mg sulphate.
Time frame: till two hours after cesarian section
2 secondary outcomes
o changes in levels of interleukin 6 (IL-6) in plasma before and after start of treatment in response to any change in brain activity
Time frame: two hours after cesarian section
o The difference in umbilical blood flow indices by Doppler.
Time frame: two hours after cesarian section
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: Yes
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.
HossamElden G Fakhry, DR 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 1 study testing Dexamedotomidine added to Magnesium sulfate and Magnesium sulfate in people with Intracranial Pressure Control in Pre-eclampsia, 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 6 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 22 Feb 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Hossam Elden G Fakhry, DR (01026269773 ext. 088, dr.hossam.hg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
will be Optic nerve sheath diameter (ONSD) changes by using ultrasound as an indicator for changes in intracranial pressure in response to treatment with either mg sulphate alone or dexamedotomidine as an adjuvant to mg sulphate. (time frame: till two hours after cesarian section). 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 22 Feb 2022.