Intravenous Magnesium Sulphate in Acute Ischemic Stroke

Dow University of Health Sciences

Status and phase: Unknown; Early Phase 1

Conditions: Ischemic Stroke; Stroke

Treatments: Drug: Magnesium Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT04412850

huda01

Details and patient eligibility

About

Magnesium has a neuroprotective role so the investigators aim to evaluate the role of intravenous magnesium sulphate in improving the clinical outcomes as assessed by the NIH Stroke Scale (NIHSS) in patients with acute ischemic stroke.

Enrollment: 44 estimated patients

Sex: All

Ages: 45 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults with a confirmed diagnosis of ischemic stroke on neurological examination and CT scan findings aged between 45 -95 years of age of either gender.
• Adults presenting within a stroke onset of 24 hours.

Exclusion criteria

• Patients with confirmed diagnosis other than ischemic stroke (evidence of Intracranial bleed or space occupying lesion)

  • Subjects with systolic blood pressure less than 90mmHg
  • Presence of Bundle Branch block or atrioventricular block.
  • Serum Creatinine > 3mg/dl
  • Respiratory failure (O2 saturation <90% or Respiratory Rate >24 or <12)
  • Pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups, including a placebo group

Control group

Experimental group

Description:

Magnesium will be given intravenously with a loading dose of 4 g in 50 mL saline over a 15-minute period and 16 g in 100 mL over a 24-hour period in a continuous-infusion form. The regiment chosen for this study is designed to double serum magnesium concentration to twice physiological concentration for therapeutic effects in humans, Serum levels between 4.8mg/dl-6mg/dl are considered to have an optimal neuroprotective effect.

Treatment:

Drug: Magnesium Sulfate

placebo group

Placebo Comparator group

Description:

Normal Saline in equal volume as the control group.

Treatment:

Drug: Magnesium Sulfate