Postoperative Orthostatic Hypotension, Postoperative Orthostatic Intolerance
Conditions
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.
Interventions
DRUGMidodrine
Midodrine 5mg as capsule, administered twice (5 and 23 hours after end of surgery).
DRUGPlacebo
Placebo capsule to mimic midodrine
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Orthostatic hypotension | 6 hours after surgery | Orthostatic hypotension (OH) during early mobilization 6 hours after end of surgery. OH is classified according to international consensus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Orthostatic hypotension 24 hours after surgery | 24 hours after end of surgery. | — |
| Orthostatic Intolerance | 6 and 24 hours after end of surgery | Orthostatic intolerance is defined as subjective presyncopal symptoms (dizziness, nausea etc.) during mobilization after surgery |
| Treatment side effects | 6 and 24 hours after end of surgery | The following side effects to Midodrine are evaluated: * Pruritus * Headache * Supine hypertension * Urinary retention |
Other
| Measure | Time frame | Description |
|---|---|---|
| Haemodynamic response to mobilization 6 and 24 hours after surgery | 6 and 24 hours after end of surgery | Haemodynamic response to mobilization (supine, sitting and standing): * Response in systolic and diastolic blood pressure * Response in heart rate. * Response in calculated haemodynamic variables (stroke volume, peripheral resistance) |
| Heart rate variability | before surgery, 6- and 24 hours after surgery | Heart rate variability measures including spectral analysis and LF/HF ratio at rest and during mobilization. |
Countries
Denmark
Outcome results
None listed