Preeclampsia SevereNCT05610774
Optic Nerve Sheath Diameter in Pre-Eclamptic Parturient Receiving Magnesium Sulfate Combined With Dexmedetomidine
A study testing Dexmedetomidine and Saline in people with Preeclampsia Severe and Optic Nerve Sheath Diameter, run by Benha University at 1 site in Egypt.
Trial summary
Dexmedetomidine was reported to effectively reduce cerebral metabolism and ICP by decreasing cerebrospinal fluid pressure in patients with cerebral tumors or head injuries that require craniotomy. However, it was also reported to exhibit no effect on ICP. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preeclampsia Severe, Optic Nerve Sheath Diameter
- What is being tested?
- Dexmedetomidine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jun 2023to 15 Jun 2024
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- aged18 to 40 years with
- at least 36 weeks gestation
- admitted with diagnosis of severe pre-eclampsia and scheduled to receive Magnesium Sulphate therapy before delivery
Who cannot join
- Presence of ocular wound or Prior ocular surgery
- emergency cases, and evidence of fetal compromise
- HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet levels)
- Chronic hypertension
- Hyperthyroidism, and diabetes mellitus
- Presence of pre-existing chronic lung and/or cardiac diseases
Show all 9Show fewer
- Presence of pre-existing chronic renal and/or hepatic diseases
- Presence of any chronic diseases of central nervous system.
- known allergies to the tested drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Optic Nerve Sheath Diameter to Monitor Intracranial Tension in Pre-Eclamptic Parturient Receiving Magnesium Sulfate in Combination With Dexmedetomidine
Dexmedetomidine was reported to effectively reduce cerebral metabolism and ICP by decreasing cerebrospinal fluid pressure in patients with cerebral tumors or head injuries that require craniotomy. However, it was also reported to exhibit no effect on ICP. the effect of MgSO4 associated with dexmedetomidine on ONSD in severely pre-eclamptic parturient has been understudied . Though this study aims to evaluate the effect of dexmedetomidine infusion on raised ICP in severely pre-eclamptic parturients using ocular ultrasonography to determine ONSD as a measure of ICP.
Read the detailed description
Dexmedetomidine, a highly selective α-2-receptor agonist, is a first-line sedative medication in ICU and has been increasingly used for obstetric anesthesia. Dexmedetomidine, which provides light sedation, possesses analgesic, sympatholytic, anxiolytic properties and attenuates the stress response without significant respiratory depression. In addition, dexmedetomidine-induced stimulation of postsynaptic alpha-2 adrenergic receptor on the cerebral blood vessels can cause cerebral vasoconstriction and decrease cerebral blood flow. However, the effects of dexmedetomidine on ICP are controversial.
Clinical signs of raised ICP are not specific and often difficult to interpret, especially during pregnancy and pre-eclampsia. Though the use of invasive devices is considered a gold standard in the measurement of ICP, Ocular sonography is a promising bedside tool, which serves as a noninvasive, readily available, and cost-effective means for indirectly measuring ICP.
Bedside ultrasound can be used as a point-of-care tool for rapidly measuring the optic nerve sheath diameter (ONSD), which is a validated indirect means for measuring ICP. An increase in ICP reflects as a raised ONSD since the optic nerve is surrounded by Dural sheath and cerebrospinal fluid (CSF) containing subarachnoid space, which is distensible in the retrobulbar segment, particularly when CSF pressures rise.
- Conditions
- Preeclampsia Severe, Optic Nerve Sheath Diameter
- Being tested
- Dexmedetomidine, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
pre-eclamptic Patients will receive a loading dose of iv dexmedetomidine (0.5 ug/kg) diluted in 50 ml saline and given over 10 min, followed by a maintenance infusion of (0.2 ug/kg/h) diluted in 200 ml saline till The sedation scores on the Richmond Agitation and Sedation Scale was -2 to +1 (lightly sedated to restless).
SalineDrug
pre-eclamptic patients will receive 50 ml saline loading for 10 min followed by 200 ml saline infusion
| Study group | Role | What they receive |
|---|---|---|
| Group (D) | Experimental | Patients will receive a loading dose of iv dexmedetomidine followed by a maintenance infusion. Receives: Drug: Dexmedetomidine |
| Group (C) | Placebo comparator | patients will receive saline loading and infusion Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter (ONSD) measurments following Drug administration
Measured: Baseline (before starting MgSO4 therapy) then at 1, 6, 12 and 24 hours postoperative
Secondary outcomes (5)
The incidence of raised ICP in severe pre-eclampsia
ONSD >5.0 mm
Measured: Baseline (before starting MgSO4 therapy), and during 24 hours postoperative.
Sedation Score
the Richmond Agitation and Sedation Scale (RASS), on which scores range from -5 [unresponsive] to +4 [combative].
Measured: every 2 hours after drug infusion, till 24 postoperative hours
Heart Rate (HR)
Measured: Baseline (before starting MgSO4 therapy) then every 2 hours till 24 postoperative hours
mean arterial pressure (MAP) changes.
Measured: Baseline (before starting MgSO4 therapy) then every 2 hours till 24 postoperative hours
The duration of hospital stay
defined as time from the day of operation to the day of discharge
Measured: one month after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start6 Jun 2023
- Primary completion10 May 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preeclampsia SevereStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Rafik Mohamed Amin, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610774
- Sponsor's protocol ID
- RC 23.9.2022
- Status last verified
- May 2025
- First submitted
- 1 Nov 2022
- Last updated
- 23 May 2025
- 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 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Optic Nerve Sheath Diameter to Monitor Intracranial Tension in Pre-Eclamptic Parturient Receiving Magnesium Sulfate in Combination With Dexmedetomidine
- ClinicalTrials.gov ID
- NCT05610774
- Acronym / sponsor ID
- RC 23.9.2022
- Conditions
- Preeclampsia Severe, Optic Nerve Sheath Diameter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 9 Nov 2022 (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.
Dexmedetomidine was reported to effectively reduce cerebral metabolism and ICP by decreasing cerebrospinal fluid pressure in patients with cerebral tumors or head injuries that require craniotomy. However, it was also reported to exhibit no effect on ICP. the effect of MgSO4 associated with dexmedetomidine on ONSD in severely pre-eclamptic parturient has been understudied . Though this study aims to evaluate the effect of dexmedetomidine infusion on raised ICP in severely pre-eclamptic parturients using ocular ultrasonography to determine ONSD as a measure of ICP.
Detailed description
Dexmedetomidine, a highly selective α-2-receptor agonist, is a first-line sedative medication in ICU and has been increasingly used for obstetric anesthesia. Dexmedetomidine, which provides light sedation, possesses analgesic, sympatholytic, anxiolytic properties and attenuates the stress response without significant respiratory depression. In addition, dexmedetomidine-induced stimulation of postsynaptic alpha-2 adrenergic receptor on the cerebral blood vessels can cause cerebral vasoconstriction and decrease cerebral blood flow. However, the effects of dexmedetomidine on ICP are controversial.
Clinical signs of raised ICP are not specific and often difficult to interpret, especially during pregnancy and pre-eclampsia. Though the use of invasive devices is considered a gold standard in the measurement of ICP, Ocular sonography is a promising bedside tool, which serves as a noninvasive, readily available, and cost-effective means for indirectly measuring ICP.
Bedside ultrasound can be used as a point-of-care tool for rapidly measuring the optic nerve sheath diameter (ONSD), which is a validated indirect means for measuring ICP. An increase in ICP reflects as a raised ONSD since the optic nerve is surrounded by Dural sheath and cerebrospinal fluid (CSF) containing subarachnoid space, which is distensible in the retrobulbar segment, particularly when CSF pressures rise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (D) | Experimental | Drug: DexmedetomidinePatients will receive a loading dose of iv dexmedetomidine followed by a maintenance infusion. |
| Group (C) | Placebo comparator | Drug: Salinepatients will receive saline loading and infusion |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged18 to 40 years with
- at least 36 weeks gestation
- admitted with diagnosis of severe pre-eclampsia and scheduled to receive Magnesium Sulphate therapy before delivery
Key exclusion criteria (9 listed)
- Presence of ocular wound or Prior ocular surgery
- emergency cases, and evidence of fetal compromise
- HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet levels)
- Chronic hypertension
- Hyperthyroidism, and diabetes mellitus
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 |
|---|---|---|
| Dexmedetomidinepre-eclamptic Patients will receive a loading dose of iv dexmedetomidine (0.5 ug/kg) diluted in 50 ml saline and given over 10 min, followed by a maintenance infusion of (0.2 ug/kg/h) diluted in 200 ml saline till The sedation scores on the Richmond Agitation and Sedation Scale was -2 to +1 (lightly sedated to restless). | Drug | Group (D) |
| Salinepre-eclamptic patients will receive 50 ml saline loading for 10 min followed by 200 ml saline infusion | Drug | Group (C) |
Primary outcome
Optic nerve sheath diameter (ONSD) measurments following Drug administration
Time frame: Baseline (before starting MgSO4 therapy) then at 1, 6, 12 and 24 hours postoperative
5 secondary outcomes
The incidence of raised ICP in severe pre-eclampsia
Time frame: Baseline (before starting MgSO4 therapy), and during 24 hours postoperative.
Sedation Score
Time frame: every 2 hours after drug infusion, till 24 postoperative hours
Heart Rate (HR)
Time frame: Baseline (before starting MgSO4 therapy) then every 2 hours till 24 postoperative hours
mean arterial pressure (MAP) changes.
Time frame: Baseline (before starting MgSO4 therapy) then every 2 hours till 24 postoperative hours
The duration of hospital stay
Time frame: one month after delivery
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 23 May 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Saline in people with Preeclampsia Severe and Optic Nerve Sheath Diameter, run by Benha 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 3 inclusion and 9 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 23 May 2025. 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.
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?
Optic nerve sheath diameter (ONSD) measurments following Drug administration (time frame: Baseline (before starting MgSO4 therapy) then at 1, 6, 12 and 24 hours postoperative). 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 23 May 2025.