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TerminatedPhase 4ACTRN12620001267943

An assessment of the impact of midodrine on early mobilisation after hip replacement surgery

A randomised trial to assess the impact of midodrine on early mobilisation after total hip arthroplasty

Sponsor

Sir Charles Gairdner and Osborne Park Hospital Group

Enrollment

84 participants

Start Date

Feb 8, 2021

Study Type

Interventional

Conditions

Orthostatic intolerance

Summary

Total hip replacement is a common operation performed in Australia. A proportion of patients will transiently feel unable to get out of bed following this surgery due to dizziness, lightheadedness, blurred vision, nausea or low blood pressure. The medical term for this is orthostatic intolerance or orthostatic hypotension. The aim of this study is to administer a medication to investigate its effect on mobilisation after this operation.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

  • Adults, aged > 18 years old
  • Elective unilateral total hip arthroplasty under spinal anaesthesia
  • Mentally competent to provide informed own written consent in English

Exclusion Criteria22

  • Spinal anaesthesia not planned, or refused by patient
  • Chronic renal impairment
  • Creatinine >2mg/dL or 180micmol/L
  • Clinical evidence of liver failure
  • Heart failure
  • NYHA class 3 or 4
  • Ejection fraction < 30%
  • Glaucoma
  • Revision hip arthroplasty
  • Hip resurfacing surgery
  • Significant preoperative neuromuscular condition limiting mobility
  • Anaemia
  • Preoperative haemoglobin concentration < 110g/L
  • Prior diagnosis of postural hypotension
  • Patients taking digoxin
  • Pregnant/Lactating Women
  • Thyrotoxicosis
  • Pheochromocytoma
  • Allergy to Midodrine
  • Chronic urinary retention
  • Significant neuromuscular condition limiting mobility
  • Co-Enrolment in another vasopressor clinical trial

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Interventions

Patients enrolled in the trial will receive a dose of 20mg of midodrine, or placebo, two hours prior to mobilisation on the first day following surgery. This will be prescribed and recorded on the pat

Patients enrolled in the trial will receive a dose of 20mg of midodrine, or placebo, two hours prior to mobilisation on the first day following surgery. This will be prescribed and recorded on the patients usual medication prescription sheet as MIDODRINE TRIAL MEDICATION. The randomisation will be concealed to both patient and nurse administering the medication.

Locations(2)

Osborne Park Hospital - Stirling

WA, Australia

Sir Charles Gairdner Hospital - Nedlands

WA, Australia

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ACTRN12620001267943