Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the efficacy of 5 mg Midodrine (Gutron) vs. placebo on reducing the incidence of orthostatic hypotension during mobilization 6 h after a total hip arthroplasty.

Official Title
-----------------
Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty - a Randomized, Placebo Controlled Trial.

Conditions
-----------------
Postoperative Orthostatic Hypotension, Postoperative Orthostatic Intolerance

Intervention / Treatment
-----------------
* Drug: Midodrine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for primary unilateral hip arthroplasty Age >= 18 years Able to give informed consent Exclusion Criteria: General anaesthesia for the current procedure Digoxin treatment. history of renal or hepatic failure history of glaucoma history chronic urinary retention requiring treatment history of orthostatic intolerance / hypotension other autonomous nervous system disease alcohol or drug abuse current malignant disease females in the fertile age (possible pregnancy or breast feeding) Treatment with anticoagulants BMI > 40 kg/m2 Dementia or cognitive dysfunction (investigators evaluation)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midodrine<br>Midodrine Hydrochloride (5mg) administered as capsule 5 and 23 hours after end of surgery. | Drug: Midodrine<br>* Midodrine 5mg as capsule, administered twice (5 and 23 hours after end of surgery).<br>* Other names: Gutron;|
| Placebo Comparator: Placebo<br>Placebo administered as capsule 5- and 23 hours after end of surgery. | Drug: Placebo<br>* Placebo capsule to mimic midodrine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orthostatic hypotension | Orthostatic hypotension (OH) during early mobilization 6 hours after end of surgery. OH is classified according to international consensus. | 6 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orthostatic hypotension 24 hours after surgery |  | 24 hours after end of surgery. | 
| Orthostatic Intolerance | Orthostatic intolerance is defined as subjective presyncopal symptoms (dizziness, nausea etc.) during mobilization after surgery | 6 and 24 hours after end of surgery | 
| Treatment side effects | The following side effects to Midodrine are evaluated: Pruritus Headache Supine hypertension Urinary retention | 6 and 24 hours after end of surgery |