Dexamedtomidine in Control of Intracranial Pressure in Preeclampsia

NCT05119101 | Unknown Phase 1

• 1 other identifier: intracranial pressure control
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Intracranial Pressure Control in Pre-eclampsia

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  two hours after cesarian section

• o The difference in umbilical blood flow indices by Doppler.

  two hours after cesarian section

Study Arms (2)

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.

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.

Drug: Dexamedotomidine added to Magnesium sulfate

Interventions

Dexamedotomidine added to Magnesium sulfate DRUG

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

Also known as: Precedex

Dexamedotomidine adjuvant to Magnesium sulphate

Magnesium sulfate DRUG

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

Also known as: Mgso4

Magnesium sulphate

Eligibility Criteria

• Age: 25 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of medicine Assiut University

Asyut, Egypt

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• HossamElden G Fakhry, DR

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hossam Elden G Fakhry, DR

CONTACT

01026269773; dr.hossam.hg@gmail.com

Mahmoud M Kamel, MD

CONTACT

01006464560; Mahmoudkamel88.mk@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priniciple investigator

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 12, 2021
• Study Start: March 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)