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Optic Nerve Sheath Diameter in Pre-Eclamptic Parturient Receiving Magnesium Sulfate Combined With Dexmedetomidine

Primary Purpose

Preeclampsia Severe, Optic Nerve Sheath Diameter

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Saline
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preeclampsia Severe

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 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.

Sites / Locations

  • Samar Rafik AminRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group (D)

Group (C)

Arm Description

Patients will receive a loading dose of iv dexmedetomidine followed by a maintenance infusion.

patients will receive saline loading and infusion

Outcomes

Primary Outcome Measures

Optic nerve sheath diameter (ONSD) measurments following Drug administration

Secondary Outcome Measures

The incidence of raised ICP in severe pre-eclampsia
ONSD >5.0 mm
Sedation Score
the Richmond Agitation and Sedation Scale (RASS), on which scores range from -5 [unresponsive] to +4 [combative].
Heart Rate (HR)
mean arterial pressure (MAP) changes.
The duration of hospital stay
defined as time from the day of operation to the day of discharge

Full Information

First Posted
November 1, 2022
Last Updated
July 24, 2023
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT05610774
Brief Title
Optic Nerve Sheath Diameter in Pre-Eclamptic Parturient Receiving Magnesium Sulfate Combined With Dexmedetomidine
Official Title
Using Optic Nerve Sheath Diameter to Monitor Intracranial Tension in Pre-Eclamptic Parturient Receiving Magnesium Sulfate in Combination With Dexmedetomidine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia Severe, Optic Nerve Sheath Diameter

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group (D)
Arm Type
Experimental
Arm Description
Patients will receive a loading dose of iv dexmedetomidine followed by a maintenance infusion.
Arm Title
Group (C)
Arm Type
Placebo Comparator
Arm Description
patients will receive saline loading and infusion
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
pre-eclamptic patients will receive 50 ml saline loading for 10 min followed by 200 ml saline infusion
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The incidence of raised ICP in severe pre-eclampsia
Description
ONSD >5.0 mm
Time Frame
Baseline (before starting MgSO4 therapy), and during 24 hours postoperative.
Title
Sedation Score
Description
the Richmond Agitation and Sedation Scale (RASS), on which scores range from -5 [unresponsive] to +4 [combative].
Time Frame
every 2 hours after drug infusion, till 24 postoperative hours
Title
Heart Rate (HR)
Time Frame
Baseline (before starting MgSO4 therapy) then every 2 hours till 24 postoperative hours
Title
mean arterial pressure (MAP) changes.
Time Frame
Baseline (before starting MgSO4 therapy) then every 2 hours till 24 postoperative hours
Title
The duration of hospital stay
Description
defined as time from the day of operation to the day of discharge
Time Frame
one month after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samar R Amin, MD
Phone
01287793991
Email
samar.rafik@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Enas W Mahdy
Phone
01029286117
Email
enaswageh@yahoo.com
Facility Information:
Facility Name
Samar Rafik Amin
City
Banhā
State/Province
Qalubia
ZIP/Postal Code
13511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samar R. Amin, lecturer

12. IPD Sharing Statement

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Optic Nerve Sheath Diameter in Pre-Eclamptic Parturient Receiving Magnesium Sulfate Combined With Dexmedetomidine

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