CompletedPhase 3ACTRN12620001342909

MObILE study - Midodrine effect on Orthostatic IntoLErance after hip and knee replacements

A randomised placebo-controlled trial to determine the effectof oral Midodrine hydrochloride to prevent orthostatic intolerance during mobilisation following total hip and knee arthroplasty


Sponsor

Waitemata District Health Board

Enrollment

170 participants

Start Date

Jan 19, 2021

Study Type

Interventional

Conditions

Summary

After a hip or knee joint replacement it is important to mobilise (get out of bed and move) early to recover faster, and reduce the risk of complications after surgery. Mobilisation can be hindered by orthostatic intolerance, described as the development of symptoms (dizziness, nausea, vomiting, blurred vision, feeling of heat, and fainting) when standing upright. Orthostatic intolerance has been reported to happen in up to 60% of patients after surgery. Reasons include an inability of the peripheral blood vessels to constrict (tighten) properly in response to standing. Midodrine is a drug that works by constricting the peripheral blood vessels, thereby improving blood pressure. This study aims to investigate if midodrine can reduce the occurrence of orthostatic intolerance after hip and knee joint replacements. One-hundred and seventy patients will be randomised to receive either midodrine or placebo in the early postoperative period. Orthostatic intolerance will be assessed on the day of surgery (approx 6 hours after surgery), and on the first day after surgery (approx 24 hours after surgery).


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria2

  • yr or older
  • Elective primary unilateral total hip or total knee arthroplasty

Exclusion Criteria13

  • Supine hypertension >180 mmHg preoperatively
  • Chronic kidney disease (eGFR below 60 mL/min/1.73m2 for more than 3 months)
  • Hepatic failure
  • Glaucoma
  • Chronic urinary retention requiring treatment
  • Taking doxazosin
  • Documented recurrent or chronic orthostatic intolerance
  • Known autonomic nervous system dysfunction
  • TIA or stroke within the last 12 months
  • Pregnant
  • Revision surgery
  • Unable to walk pre-operatively
  • Unable to speak or understand English

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Interventions

Oral Midodrine Hydrochloride 10mg administered five times in the early postoperative period; Day of surgery; 1 tablet oral every 4 hours for 2 doses Postoperative day 1; 1 tablet oral every 4 hours

Oral Midodrine Hydrochloride 10mg administered five times in the early postoperative period; Day of surgery; 1 tablet oral every 4 hours for 2 doses Postoperative day 1; 1 tablet oral every 4 hours for 3 doses Drug administration will be carried out by a ward nurse. Prescription records and administration records will be monitored by a researcher daily, whilst patients are in the study.


Locations(1)

Auckland, New Zealand

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