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Dexamedtomidine in Control of Intracranial Pressure in Preeclampsia

Primary Purpose

Intracranial Pressure Control in Pre-eclampsia

Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Dexamedotomidine added to Magnesium sulfate
Magnesium sulfate
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intracranial Pressure Control in Pre-eclampsia

Eligibility Criteria

25 Years - 43 Years (Adult)FemaleDoes not accept healthy volunteers

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.

    -

Sites / Locations

  • Faculty of medicine Assiut UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Magnesium sulphate

Dexamedotomidine adjuvant to Magnesium sulphate

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
o The difference in umbilical blood flow indices by Doppler.

Full Information

First Posted
November 2, 2021
Last Updated
February 15, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05119101
Brief Title
Dexamedtomidine in Control of Intracranial Pressure in Preeclampsia
Official Title
Dexamedtomidine as Adjuvant to Magnesium Sulphate for Intracranial Pressure Control in Pre-eclampsia: a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Pressure Control in Pre-eclampsia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magnesium sulphate
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dexamedotomidine adjuvant to Magnesium sulphate
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamedotomidine added to Magnesium sulfate
Other Intervention Name(s)
Precedex
Intervention Description
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
Intervention Name(s)
Magnesium sulfate
Other Intervention Name(s)
Mgso4
Intervention Description
we will give mg sulphate and then measure intracranial pressure at different intervals by measuring Optic nerve sheath diameter (ONSD).
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
o The difference in umbilical blood flow indices by Doppler.
Time Frame
two hours after cesarian section

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
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: 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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hossam Elden G Fakhry, DR
Phone
01026269773
Ext
088
Email
dr.hossam.hg@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud M Kamel, MD
Phone
01006464560
Ext
088
Email
Mahmoudkamel88.mk@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HossamElden G Fakhry, DR
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine Assiut University
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hossam Elden G Fakhry, DR
Phone
01026269773
Ext
088
Email
Dr.hossam.hg@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Dexamedtomidine in Control of Intracranial Pressure in Preeclampsia

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