Dexamedtomidine in Control of Intracranial Pressure in Preeclampsia

NCT ID: NCT05119101

Last Updated: 2022-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-12-31

Brief 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

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.

Conditions

Intracranial Pressure Control in Pre-eclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Magnesium sulphate

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.

Group Type: ACTIVE_COMPARATOR

Magnesium sulfate

Intervention Type: DRUG

we will give mg sulphate and then measure intracranial pressure at different intervals by measuring Optic nerve sheath diameter (ONSD).

Dexamedotomidine adjuvant to Magnesium sulphate

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.

Group Type: ACTIVE_COMPARATOR

Dexamedotomidine added to Magnesium sulfate

Intervention Type: DRUG

we will give dexamedotomidine and mg sulphate and then measure intracranial pressure at different intervals by measuring Optic nerve sheath diameter (ONSD).

Interventions

Dexamedotomidine added to Magnesium sulfate

we will give dexamedotomidine and mg sulphate and then measure intracranial pressure at different intervals by measuring Optic nerve sheath diameter (ONSD).

Intervention Type: DRUG

Magnesium sulfate

we will give mg sulphate and then measure intracranial pressure at different intervals by measuring Optic nerve sheath diameter (ONSD).

Intervention Type: DRUG

Other Intervention Names

Precedex; Mgso4

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

1. Age: younger than 25 or older than 43.

2. Pregnant females with mild preeclampsia.

3. Patients with cerebro-vascular diseases, Glaucoma, Hepatic failure, Renal failure .

4. patient who got their MgSO4 medication before the first reading of Optic nerve sheath diameter ONSD were also excluded.

5. History of allergy to dexamedotomidine.

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• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hossam Elden Gamal Fakhry

Priniciple investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

HossamElden G Fakhry, DR

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Faculty of medicine Assiut University

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hossam Elden G Fakhry, DR

Role: CONTACT

dr.hossam.hg@gmail.com

01026269773 ext. 088

Mahmoud M Kamel, MD

Role: CONTACT

Mahmoudkamel88.mk@gmail.com

01006464560 ext. 088

Facility Contacts

Hossam Elden G Fakhry, DR

Role: primary

Dr.hossam.hg@gmail.com

01026269773 ext. 088

Other Identifiers

intracranial pressure control

Identifier Type: -

Identifier Source: org_study_id