Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty (THA)
- Conditions
- Orthostatic IntolerancePostoperative ComplicationsOrthostatic Hypotension
- Registration Number
- NCT03759574
- Lead Sponsor
- Hvidovre University Hospital
- Brief Summary
Incidence and pathophysiologic hemodynamics of orthostatic intolerance and orthostatic hypotension in patients undergoing unilateral THA
- Detailed Description
Early postoperative mobilization is a cornerstone in the so-called fast track multimodal perioperative approach and is essential in preventing postoperative morbidity and reducing hospital length-of-stay. Intact orthostatic blood pressure regulation is essential for early postoperative mobilization. However, early postoperative mobilization can be delayed due to postoperative orthostatic hypotension (POH) defined as a fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg or due to postoperative orthostatic intolerance (POI), characterized by dizziness, nausea, vomiting, blurred vision or syncope during mobilization. Although these conditions are well-known clinical problems that can delay early mobilization, relatively few data are available on pathophysiological mechanisms and possible treatments.
Several prospective studies with standardized mobilization procedures have already established that the incidence of POI and POH after THA is 38-42% at 6 hours after surgery.
Previous studies on patients undergoing prostatectomy and THA have also demonstrated that attenuated vasopressor response and a concomitant reduction in cardiac output (CO) and cerebral perfusion during postural changes after surgery contributes to POI and POH. Strategies aiming to reduce the incidence of POI and POH by pain management, vasoconstrictive treatment with alpha-1 receptor agonist, optimized fluid management with goal-directed fluid therapy and reduction of surgical stress-response with pre-operative high-dose glucocorticoid did not solve the problem.
The precise pathophysiological mechanisms of POI and POH remain to be elucidated and this is therefore the aim of the current prospective observational study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 26
- Age 18-65
- Written informed consent
- Patients that speak and understand Danish
- Patients undergoing primary unilateral total hip arthroplasty in spinal anesthesia in standardized fast-track setting
- Alcohol and drug abuse
- Cognitive dysfunction
- History of orthostatic hypotension
- Use of anxiolytic or antipsychotic drugs
- Use of opioids
- Use of following vasodilator antihypertensive drugs: beta-blockers, angiotensin converting enzyme inhibitors (ACEI), angiotensin 2 receptor blockers (ARBs), calcium channel blockers
- Use of loop diuretics, thiazid diuretics and potassium-sparing diuretics
- Use of Gabapentin
- Arrhythmias or heart failure
- Diabetes mellitus type I
- Diabetes mellitus type II
- History of following diseases in the autonomic nervous system: Parkinson disease, multiple sclerosis, autonomic neuropathies
- History of cerebral apoplexy or transitory cerebral ischemia
- Dementia
- American Society of Anesthesiologists (ASA) score ≥ 4
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of orthostatic intolerance 6 hours postoperatively Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization
Incidence of orthostatic hypotension 6 hours postoperatively Orthostatic hypotension is defined as a fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg during mobilization
- Secondary Outcome Measures
Name Time Method Changes in mean arterial pressure (MAP) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in mmHg
Changes in peripheral perfusion index (PPI) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in arbitrary units (AU)
Changes in cerebral perfusion (ScO2) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in %
Changes in total blood volume (TBV) Preoperatively, 6 and 24 hours postoperatively Measured in mL
Changes in haemoglobin (Hgb) concentration Preoperatively, 6 and 24 hours postoperatively Measured in millimoles/L
Changes in diastolic arterial pressure (DAP) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in mmHg
Changes in hematocrit Preoperatively, 6 and 24 hours postoperatively Measured in %
Changes in cardiac output (CO) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in mL/min
Changes in baroreflex sensitivity (BRS) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in ms/mmHg
Changes in stroke volume (SV) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in mL
Changes in heart rate variability (HRV) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in ms
Changes in muscular perfusion (SmO2) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in %
Changes in systemic vascular resistance (SVR) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in mmHg⋅min⋅mL-1
Changes in erythrocyte volume (ECV) Preoperatively, 6 and 24 hours postoperatively Measured in mL
Changes in systolic arterial pressure (SAP) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in mmHg
Changes in C-Reactive Protein Preoperatively, 6 and 24 hours postoperatively Measured in mg/L
Changes in plasma volume (PV) Preoperatively, 6 and 24 hours postoperatively Measured in mL
Trial Locations
- Locations (1)
Hvidovre Hospital
🇩🇰Copenhagen, Denmark