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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620001267943

Enrollment

Registered

2020-11-25

Start date

2021-02-08

Completion date

2022-02-10

Last updated

2023-02-13

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

Conditions

None listed

Brief 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.

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 patients usual medication prescription sheet as MIDODRINE TRIAL MEDICATION. The randomisation will be concealed to both patient and nurse administering the medication.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Outcome results