Intravenous Magnesium Sulphate in Acute Ischemic Stroke

Early Phase 1

• Conditions: Ischemic Stroke; Stroke
• Interventions: Drug: Magnesium Sulfate

• Registration Number: NCT04412850
• Lead Sponsor: Dow University of Health Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-11
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-01
• Last Update Submitted: 2020-06-01
• Study First Posted: 2020-06-02
• Last Update Posted: 2020-06-02
• Study Start: 2020-12-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Magnesium Sulfate	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.
placebo group	Magnesium Sulfate	Normal Saline in equal volume as the control group.

Primary Outcome Measures

Name	Time	Method
Improvement In Clinical Outcome As Measured By The improvement in NIH Stroke Scale After Infusion Of Magnesium Sulphate In Patients Suffering From Acute Ischemic Stroke.	7 days

Secondary Outcome Measures

Name	Time	Method
adverse effects	7 days