Clinical trial NCT05610774: 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
Overall status: COMPLETED
Phase: NA
Conditions: Preeclampsia Severe
Optic Nerve Sheath Diameter
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Optic nerve sheath diameter (ONSD) measurments following Drug administration
timeFrame: Baseline (before starting MgSO4 therapy) then at 1, 6, 12 and 24 hours postoperative
Secondary outcomes:
measure: The incidence of raised ICP in severe pre-eclampsia
timeFrame: Baseline (before starting MgSO4 therapy), and during 24 hours postoperative.
measure: Sedation Score
timeFrame: every 2 hours after drug infusion, till 24 postoperative hours
measure: Heart Rate (HR)
timeFrame: Baseline (before starting MgSO4 therapy) then every 2 hours till 24 postoperative hours
measure: mean arterial pressure (MAP) changes.
timeFrame: Baseline (before starting MgSO4 therapy) then every 2 hours till 24 postoperative hours
measure: The duration of hospital stay
timeFrame: one month after delivery
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Samar Rafik Amin
state: Qalubia
Study officials:
References: