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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06213935
Enrollment
90
Registered
2024-01-19
Start date
2024-02-01
Completion date
2024-11-01
Last updated
2024-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Spinal Anesthesia Hypotension

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.

Interventions

DRUGNorepinephrine

after spinal anesthesia, norepinephrine will be injected intravenous as bolus at 0.05 μg/kg, followed by norepinephrine infusion at a rate of 0.05 μg/kg.min to prevent post spinal hypotension

DRUGMidodrine

10 mg tablets of midodrine 1 hour before spinal anesthesia to prevent post spinal anesthesia hypotension

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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.

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of post spinal anesthesia hypotensionwithin 60 minutes of induction of spinal anesthesiadecrease in Mean Arterial Blood Pressure more than 20% of the baseline reading

Secondary

MeasureTime frameDescription
Intraoperative ephedrine consumptionwithin 60 minutes of induction of spinal anesthesiaephedrine dose injected intravenous to control post spinal hypotension
Incidence of post spinal anesthesia bradycardiawithin 60 minutes of induction of spinal anesthesiadecrease in Heart Rate less than 50 Beats per minutes

Contacts

Primary ContactAndrew R Khalafallah, Resident
andrewramsis@med.sohag.edu.eg01284160711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026