Midodrine for Prophylaxis Against Post Spinal Hypotension in Elderly Population

NCT05548985 | Completed

• 1 other identifier: MD-25-2021
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hypotension; Spinal Anesthesia; Elderly

Outcome Measures

Primary Outcomes (1)

• Intraoperative ephedrine consumption

  mg

  1 minutes after spinal injection until 45 minutes after induction of spinal anesthesia

Secondary Outcomes (5)

• Incidence of post-spinal hypotension

  1 minutes after spinal injection until 45 minutes after induction of spinal anesthesia

• Incidence of severe spinal induced hypotension

  1 minutes after spinal injection until 45 minutes after induction of spinal anesthesia

• Incidence of bradycardia

  1 minutes after spinal injection until 45 minutes after induction of spinal anesthesia

• heart rate

  1 minute after intervention, every 15 minutes after intervention for 90 minutes, every 2 minutes after spinal anesthesia for 20 min, then every 5 minutes until the end of the procedure

• mean arterial pressure

  1 minute after intervention, every 15 minutes after intervention for 90 minutes, every 2 minutes after spinal anesthesia for 20 min, then every 5 minutes until the end of the procedure

Study Arms (2)

control group

PLACEBO COMPARATOR

oral metoclopramide 10 mg, Metoclopramide tablet was chosen as a placebo because it has the same appearance of midodrine tablet with no cardiovascular effects

Drug: Metoclopramide

Midodrine group

ACTIVE COMPARATOR

oral midodrine tablet (5 mg)

Drug: Midodrine Oral Tablet

Interventions

Midodrine Oral Tablet DRUG

oral midodrine tablet (5 mg) 90 min before performing spinal block

Midodrine group

Metoclopramide DRUG

oral placebo (metoclopramide 10 mg tablet). 90 min before performing spinal block

control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Elderly patients (\>65).
• ASA I-II-III.
• Scheduled for hip joint surgery under spinal anaesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (1)

• Amin S, Hasanin A, Mansour R, Mostafa M, Zakaria D, Arafa AS, Yassin A, Ziada H. Oral midodrine for prophylaxis against post-spinal anesthesia hypotension during hip arthroplasty in elderly population: a randomized controlled trial. BMC Anesthesiol. 2024 Feb 14;24(1):64. doi: 10.1186/s12871-024-02442-8.

  PMID: 38355397 DERIVED

MeSH Terms

Conditions

Hypotension

Interventions

Midodrine; Metoclopramide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2022
• First Posted: September 22, 2022
• Study Start: October 17, 2022
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)