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

NCT06213935 | Unknown

• 1 other identifier: Soh-Med-23-12-01MS
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post Spinal Anesthesia Hypotension

Outcome Measures

Primary Outcomes (1)

• Incidence of post spinal anesthesia hypotension

  decrease in Mean Arterial Blood Pressure more than 20% of the baseline reading

  within 60 minutes of induction of spinal anesthesia

Secondary Outcomes (2)

• Intraoperative ephedrine consumption

  within 60 minutes of induction of spinal anesthesia

• Incidence of post spinal anesthesia bradycardia

  within 60 minutes of induction of spinal anesthesia

Study Arms (2)

group A

ACTIVE COMPARATOR

will receive a norepinephrine bolus at 0.05 μg/kg, followed by norepinephrine infusion at a rate of 0.05 μg/kg.min

Drug: Norepinephrine

Group B

ACTIVE COMPARATOR

will receive 10 mg tablets of midodrine 1 hour before spinal anesthesia.

Drug: Midodrine

Interventions

Norepinephrine DRUG

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

group A

Midodrine DRUG

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

Group B

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patient refusal.
• Contraindication to spinal anesthesia .
• Patients known allergic to Midodrine or Norepinephrine.
• Patients with preexisting cardiovascular or cerebrovascular disease.
• Patients with diabetes mellitus.
• Patients with psychiatric disease or on psychiatric treatment.

Sponsors & Collaborators

• Sohag University: lead

Related Publications (4)

• McCrae AF, Wildsmith JA. Prevention and treatment of hypotension during central neural block. Br J Anaesth. 1993 Jun;70(6):672-80. doi: 10.1093/bja/70.6.672.

  PMID: 8329261 BACKGROUND

• Alseoudy MM, Nasr MO, Abdelsalam TA. Efficacy of Preoperative Oral Midodrine in Preventing Hypotension After Spinal Anesthesia in Young Adults: A Randomized Controlled Trial. Anesth Analg. 2022 Nov 1;135(5):1089-1096. doi: 10.1213/ANE.0000000000006173. Epub 2022 Aug 10.

  PMID: 35950781 BACKGROUND

• Quaglia MG, Farina A, Palmery M, Desideri N, Donati E, Bossu E, Strano S. Chiral investigation of midodrine, a long-acting alpha-adrenergic stimulating agent. Chirality. 2004 Jul;16(6):356-62. doi: 10.1002/chir.20041.

  PMID: 15190580 BACKGROUND

• Gutman LB, Wilson BJ. The Role of Midodrine for Hypotension Outside of the Intensive Care Unit. J Popul Ther Clin Pharmacol. 2017 Aug 23;24(3):e45-e50. doi: 10.22374/1710-6222.24.3.4.

  PMID: 28873293 BACKGROUND

MeSH Terms

Interventions

Norepinephrine; Midodrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Andrew R Khalafallah, Resident

CONTACT

01284160711; andrewramsis@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia,Intensive Care and Pain control department, Sohag university hospital

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 19, 2024
• Study Start: February 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01