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

NCT05610774 | Completed

• 1 other identifier: RC 23.9.2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia Severe; Optic Nerve Sheath Diameter

Outcome Measures

Primary Outcomes (1)

• Optic nerve sheath diameter (ONSD) measurments following Drug administration

  Baseline (before starting MgSO4 therapy) then at 1, 6, 12 and 24 hours postoperative

Secondary Outcomes (5)

• The incidence of raised ICP in severe pre-eclampsia

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

• Sedation Score

  every 2 hours after drug infusion, till 24 postoperative hours

• Heart Rate (HR)

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

• mean arterial pressure (MAP) changes.

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

• The duration of hospital stay

  one month after delivery

Study Arms (2)

Group (D)

EXPERIMENTAL

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

Drug: Dexmedetomidine

Group (C)

PLACEBO COMPARATOR

patients will receive saline loading and infusion

Drug: Saline

Interventions

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).

Group (D)

Saline DRUG

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

Group (C)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Samar Rafik Amin

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and surgical ICU

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 9, 2022
• Study Start: June 6, 2023
• Primary Completion: May 10, 2024
• Study Completion: June 15, 2024
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

EG (1)