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NCT Number: NCT05610774

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

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Key information

Conditions

Preeclampsia Severe Optic Nerve Sheath Diameter

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samar Rafik Amin

Banhā, Qalyubia Governorate, 13511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

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).

Saline

Drug

pre-eclamptic patients will receive 50 ml saline loading for 10 min followed by 200 ml saline infusion

Primary outcomes

  1. 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 outcomes

  1. The incidence of raised ICP in severe pre-eclampsia

    Time frame: Baseline (before starting MgSO4 therapy), and during 24 hours postoperative.

    ONSD >5.0 mm

  2. Sedation Score

    Time frame: every 2 hours after drug infusion, till 24 postoperative hours

    the Richmond Agitation and Sedation Scale (RASS), on which scores range from -5 [unresponsive] to +4 [combative].

  3. Heart Rate (HR)

    Time frame: Baseline (before starting MgSO4 therapy) then every 2 hours till 24 postoperative hours

  4. mean arterial pressure (MAP) changes.

    Time frame: Baseline (before starting MgSO4 therapy) then every 2 hours till 24 postoperative hours

  5. The duration of hospital stay

    Time frame: one month after delivery

    defined as time from the day of operation to the day of discharge

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Using Optic Nerve Sheath Diameter to Monitor Intracranial Tension in Pre-Eclamptic Parturient Receiving Magnesium Sulfate in Combination With Dexmedetomidine

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 9, 2022
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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