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Clinical trial

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

ID
Name
RC 23.9.2022
Description
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.
Trial arms
Trial start
2022-12-20
Estimated PCD
2024-07-10
Trial end
2024-07-25
Status
Recruiting
Treatment
Dexmedetomidine
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).
Arms:
Group (D)
Saline
pre-eclamptic patients will receive 50 ml saline loading for 10 min followed by 200 ml saline infusion
Arms:
Group (C)
Size
50
Primary endpoint
Optic nerve sheath diameter (ONSD) measurments following Drug administration
Baseline (before starting MgSO4 therapy) then at 1, 6, 12 and 24 hours postoperative
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-05-17

1 organization

1 product

1 drug

2 indications

Organization
Benha University
Product
Dexmedetomidine
Indication
Preeclampsia Severe
Indication
optic nerve sheath diameter
Drug
Varlilumab