Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty in Patients Receiving ACEIs and ARBs
- Conditions
- Orthostatic HypotensionOrthostatic Intolerance
- Interventions
- Other: Mobilisation procedure
- Registration Number
- NCT04842058
- Lead Sponsor
- Hvidovre University Hospital
- Brief Summary
Incidence and pathophysiologic hemodynamics of postoperative orthostatic intolerance and orthostatic hypotension in patients receiving antihypertensives
- Detailed Description
Early postoperative mobilization is essential for rapid functional recovery after surgery and it is considered a cornerstone in the so-called fast track multimodal perioperative approach, which includes early ambulation, oral nutrition, multimodal opioid-sparing analgesia and optimized fluid therapy. This strategy has improved patient outcome after surgery and reduced hospital length of stay. Immobilization after surgery is associated with increased risk of complications including venous thromboembolism (deep venous thrombosis, pulmonary embolism), muscle wasting, pneumonia and atelectasis, thereby impending convalescence.
However, early postoperative mobilization can be delayed due to failed orthostatic cardiovascular regulation, resulting in postoperative orthostatic hypotension (OH), defined as a decrease in systolic blood pressure \> 20 mmHg or diastolic blood pressure \> 10 mmHg or postoperative orthostatic intolerance (OI), characterized by dizziness, nausea, vomiting, visual disturbances or syncope.
Previous studies investigating the incidence and pathophysiology of postoperative OI and OH included mixed patient populations. Hitherto no studies have been performed looking into the incidence and pathophysiologic hemodynamics of postoperative OI and OH specifically in patients receiving angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs), antihypertensive agents with potential effects on cardiovascular compensatory functions.
The current study aims therefore to estimate the incidence and gain knowledge on pathophysiological hemodynamics of postoperative OI and OH in patients receiving ACEIs and ARBs.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 24
- Patients undergoing primary unilateral total hip arthroplasty (THA) in spinal anaesthesia in standardized fast-track setting
- Habitual use of angiontensin-Converting Enzyme Inhibitors (ACEIs) and/or angiotensin 2 receptor blockers (ARBs) on any indication
- Patients > 18
- Patients that understand and speak Danish
- Patients that have provided written informed consent
- Alcohol abuse
- Any type of substance abuse
- Chronic pain treated by habitual use of opioids
- Habitual use of anxiolytic, antidepressant and/or antipsychotic drugs
- History of cerebral apoplexy or transitory cerebral ischemia
- History of previous orthostatic intolerance or hypotension
- History of diabetes mellitus
- History of following diseases of the autonomic nervous system: Parkinson disease, multiple sclerosis, multiple system atrophy, autonomic neuropathies
- Cognitive dysfunction
- Dementia
- American Society of Anesthesiologists (ASA) > 3
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Orthostatic intolerant patients (OI) Mobilisation procedure Patients that do not experience symptoms of orthostatic intolerance (dizziness, nausea, vomiting, blurry vision or syncope) or orthostatic hypotension (fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg) during mobilisation Orthostatic tolerant patients (OT) Mobilisation procedure Patients that experience symptoms of orthostatic intolerance (dizziness, nausea, vomiting, blurry vision or syncope) or orthostatic hypotension (fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg) during mobilisation
- Primary Outcome Measures
Name Time Method 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
Incidence of orthostatic intolerance 6 hours postoperatively Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization
- Secondary Outcome Measures
Name Time Method Changes in Diastolic Sympathetic Index 1 (DSI1) during Valsalva manoeuvre Preoperatively, 6 and 24 hours postoperatively Measured as index
Changes in mean arterial pressure (MAP) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in mmHg by non-invasive LiDCO
Changes in heart rate (HR) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in beats min-1 by non-invasive LiDCO
Changes in red blood cell volume (RBCV) Preoperatively, 6 and 24 hours postoperatively Measured in mL by Carbon Monoxide - rebreathing technique
Changes in muscular perfusion (SmO2) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in % by Root Masimo
Changes in peripheral perfusion index (PPI) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in % by Root Masimo
Changes in systolic arterial pressure (SAP) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in mmHg by non-invasive Lithium Dilution Cardiac Output (LiDCO) measurement
Changes in C-Reactive Protein Preoperatively, 6 and 24 hours postoperatively Measured in mg/L
Changes in Systolic Sympathetic Index 1 (SSI1) during Valsalva manoeuvre Preoperatively, 6 and 24 hours postoperatively Measured as index
Changes in diastolic arterial pressure (DAP) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in mmHg by non-invasive LiDCO
Changes in systemic vascular resistance (SVR) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in dynes s cm-5 by non-invasive LiDCO
Changes in cardiac output (CO) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in L/min by non-invasive LiDCO
Changes in stroke volume (SV) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in mL by non-invasive LiDCO
Changes in pulse pressure (PP) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in mmHg
Changes in cerebral perfusion (ScO2) during mobilization Preoperatively, 6 and 24 hours postoperatively Measured in % by Root Masimo
Changes in total blood volume (TBV) Preoperatively, 6 and 24 hours postoperatively Measured in mL by Carbon Monoxide - rebreathing technique
Changes in heart rate variability (HRV) during Valsalva manoeuvre Preoperatively, 6 and 24 hours postoperatively Measured in ms
Changes in baroreflex sensitivity - vagal (BRSv) during Valsalva manoeuvre Preoperatively, 6 and 24 hours postoperatively Measured in ms
Changes in plasma volume (PV) Preoperatively, 6 and 24 hours postoperatively Measured in mL by Carbon Monoxide - rebreathing technique
Changes in hematocrit Preoperatively, 6 and 24 hours postoperatively Measured in %
Changes in total mass of hemoglobin Preoperatively, 6 and 24 hours postoperatively Measured in grams
Changes in hemoglobin concentration Preoperatively, 6 and 24 hours postoperatively Measured in gr/L
Changes in Valsalva ratio (VR) during Valsalva manoeuvre Preoperatively, 6 and 24 hours postoperatively Measured as index
Changes in Systolic Sympathetic Index 3 (SSI3) during Valsalva manoeuvre Preoperatively, 6 and 24 hours postoperatively Measured as index
Changes in Diastolic Sympathetic Index 2 (DSI2) during Valsalva manoeuvre Preoperatively, 6 and 24 hours postoperatively Measured as index
Changes in Pressure Recovery Time (PRT) during Valsalva manoeuvre Preoperatively, 6 and 24 hours postoperatively Measured in seconds
Changes in Baroreceptor Reflex Sensitivity-adrenergic (BRS-a) during Valsalva manoeuvre Preoperatively, 6 and 24 hours postoperatively Measured in seconds
Changes in systolic latency during Valsalva manoeuvre Preoperatively, 6 and 24 hours postoperatively Measured in seconds
Changes in diastolic latency during Valsalva manoeuvre Preoperatively, 6 and 24 hours postoperatively Measured in seconds
Changes in Diastolic Sympathetic Index 3 (DSI3) during Valsalva manoeuvre Preoperatively, 6 and 24 hours postoperatively Measured as index
Changes in Systolic Sympathetic Index 2 (SSI2) during Valsalva manoeuvre Preoperatively, 6 and 24 hours postoperatively Measured as index
Trial Locations
- Locations (1)
Hvidovre University Hospital
🇩🇰Copenhagen, Denmark