Preoperative Oral Midodrine Versus Intraoperative Intravenous Norepinephrine in Preventing Post-spinal Anesthesia Hypotension in Cesarean Section: A Prospective Double-blind Randomized Clinical Trial

Not Applicable

Not yet recruiting

• Conditions: Post Spinal Anesthesia Hypotension
• Interventions: Drug: Midodrine; Drug: Norepinephrine

• Registration Number: NCT06213935
• Lead Sponsor: Sohag University

Brief Summary

Neuraxial blockade such as spinal anaesthesia can cause severe hypotension due to pharmacological sympathectomy resulting in potential deleterious consequences for the patient, Prevention of this spinal anaesthesia induced hypotension is of utmost importance, Techniques currently in use for preventing hypotension include intravenous fluid prehydration, sympathomimetic drugs, and physical methods such as positioning and leg compression.

Midodrine is an orally active α-adrenergic agonist ,Used in clinical management of patients with orthostatic hypotension or hypotension secondary to other clinical conditions or drug therapies. Midodrine is almost completely absorbed after oral administration and undergoes enzymatic hydrolysis to form its pharmacologically active metabolite, de-glymidodrine , causes venous and arterial vasoconstriction through stimulation of α1- receptors located in the vasculature, However ,Midodrine may cause several side effects as chills ,numbness , tingling ,paresthesia ,polyuria ,dysuria and headache.

On the other hand, Norepinephrine is a vasoconstrictor that predominantly stimulates α1 receptors to cause peripheral vasoconstriction and increase blood pressure. It also has some β1 receptor agonist activity that results in a positive inotropic effect on the heart at higher doses. Norepinephrine also may cause side effects as headache, blurred vision, chest pain ,nervousness, bradycardia or tachycardia.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-19
• Last Update Posted: 2024-01-19
• Study Start: 2024-02-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

1. The study will include 90 adult female patients, 45 in each group (between 18-35 years old).
2. patients of ASA physical status class I and class II.
3. patients scheduled for elective cesarean section under spinal anesthesia.

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Exclusion Criteria

1. Patient refusal.
2. Contraindication to spinal anesthesia .
3. Patients known allergic to Midodrine or Norepinephrine.
4. Patients with preexisting cardiovascular or cerebrovascular disease.
5. Patients with diabetes mellitus.
6. Patients with psychiatric disease or on psychiatric treatment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Midodrine	will receive 10 mg tablets of midodrine 1 hour before spinal anesthesia.
group A	Norepinephrine	will receive a norepinephrine bolus at 0.05 μg/kg, followed by norepinephrine infusion at a rate of 0.05 μg/kg.min

Primary Outcome Measures

Name	Time	Method
Incidence of post spinal anesthesia hypotension	within 60 minutes of induction of spinal anesthesia	decrease in Mean Arterial Blood Pressure more than 20% of the baseline reading

Secondary Outcome Measures

Name	Time	Method
Intraoperative ephedrine consumption	within 60 minutes of induction of spinal anesthesia	ephedrine dose injected intravenous to control post spinal hypotension
Incidence of post spinal anesthesia bradycardia	within 60 minutes of induction of spinal anesthesia	decrease in Heart Rate less than 50 Beats per minutes