Midodrine for Prophylaxis Against Post Spinal Hypotension in Elderly Population

• Status: Not yet recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Hip fracture is a common and serious healthcare problem which commonly affects elderly populations. The common route of anesthesia for hip arthroplasty is spinal anesthesia. Elderly populations are characterized by high incidence of post spinal anesthesia hypotension; furthermore, elderly patients commonly have systemic medical disorder; therefore, this population is highly vulnerable to perioperative hypotension. Moreover , intraoperative hypotension during hip surgery has been recently recognized as a major risk factor for postoperative morbidity and mortality.

Through the effect of spinal anesthesia on sympathetic system Veno-dilatation, decreased venous return, and consequently decreased cardiac output and hypotension will be induced. Vasopressors are commonly used for prophylaxis against post spinal hypotension in different patient subgroups. The commonly used drugs are alpha-adrenoreceptor agonists such as ephedrine, phenylephrine, and recently norepinephrine. All these agents are effective in maintenance of blood pressure; however, they have some disadvantages; ephedrine is commonly associated with tachycardia, phenylephrine and norepinephrine are associated with bradycardia. All the former mentioned drugs are used intravenously.

Midodrine hydrochloride is another alpha-adrenoreceptor agonist drug which is used for management of various hypotensive disorders. Midodrine is the prodrug which is metabolized to desglymidodrine which is a direct arteriolar and venous vasopressor. Midodrine is characterized by being an oral drug, with minimal central nervous system side effects, and good oral bioavailability. No studies had evaluated the efficacy of midodrine for prophylaxis against post-spinal anesthesia hypotension in elderly population.

Aim of the work:

This thesis aims to evaluate the efficacy and safety of oral 5 mg of midodrine compared to placebo in prophylaxis against post-spinal hypotension in elderly patients undergoing hip arthroplasty

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Metoclopramide; Midodrine

Criteria

Inclusion Criteria:

• Elderly patients (>65).

• ASA I-II-III.

• Scheduled for hip joint surgery under spinal anaesthesia

Exclusion Criteria:

• • Uncontrolled hypertension

• Liver cell failure (child B or C).

• Chronic renal failure on regular dialysis

• Contraindications of spinal anaesthesia

• History of allergy to midodrine

• Cardiac morbidities (impaired contractility with ejection fraction < 50%, heart block, arrhythmias, tight valvular lesions).

• Acute renal disease, urinary retention

• Patients on negative chronotropic drugs (such as beta blocker) or vasoconstrictor

• Patients with glaucoma