Brief Title
Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty (THA)
Official Title
Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty
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.
Study Type
Observational
Primary Outcome
Incidence of orthostatic intolerance
Secondary Outcome
Changes in systolic arterial pressure (SAP) during mobilization
Condition
Orthostatic Intolerance
Study Arms / Comparison Groups
Orthostatic intolerant (OI)
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
26
Start Date
March 18, 2019
Completion Date
May 15, 2021
Primary Completion Date
January 1, 2021
Eligibility Criteria
Inclusion Criteria: - 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 Exclusion Criteria: - 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
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
, +4538621508, [email protected]
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT03759574
Organization ID
H-18052195
Responsible Party
Principal Investigator
Study Sponsor
Hvidovre University Hospital
Collaborators
Henrik Kehlet
Study Sponsor
, ,
Verification Date
January 2020