Clinical trial NCT04842058: Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty in Patients Receiving ACEIs and ARBs
Official title: Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty in Patients Receiving Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin II Receptor Blockers (ARBs)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Orthostatic Intolerance
Orthostatic Hypotension
Keywords: Orthostatic Hypotension
Orthostatic Intolerance
Postoperative period
Antihypertensives
Autonomic dysfunction
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Kehlet, Henrik, M.D., Ph.D.
First posted: 2021-04-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving antuhypertensives (ACEIs, ARBs) and undergoing primary unilateral total hip arthroplasty in spinal anesthesia in standardized fast-track setting

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of orthostatic intolerance
timeFrame: 6 hours postoperatively
measure: Incidence of orthostatic hypotension
timeFrame: 6 hours postoperatively
Secondary outcomes:
measure: Changes in systolic arterial pressure (SAP) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in diastolic arterial pressure (DAP) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in mean arterial pressure (MAP) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in systemic vascular resistance (SVR) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in cardiac output (CO) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in stroke volume (SV) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in heart rate (HR) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in pulse pressure (PP) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in cerebral perfusion (ScO2) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in muscular perfusion (SmO2) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in peripheral perfusion index (PPI) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in total blood volume (TBV)
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in red blood cell volume (RBCV)
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in plasma volume (PV)
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in hematocrit
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in total mass of hemoglobin
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in hemoglobin concentration
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in C-Reactive Protein
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in heart rate variability (HRV) during Valsalva manoeuvre
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in baroreflex sensitivity - vagal (BRSv) during Valsalva manoeuvre
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in Valsalva ratio (VR) during Valsalva manoeuvre
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in Systolic Sympathetic Index 1 (SSI1) during Valsalva manoeuvre
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in Systolic Sympathetic Index 2 (SSI2) during Valsalva manoeuvre
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in Systolic Sympathetic Index 3 (SSI3) during Valsalva manoeuvre
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in Diastolic Sympathetic Index 1 (DSI1) during Valsalva manoeuvre
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in Diastolic Sympathetic Index 2 (DSI2) during Valsalva manoeuvre
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in Diastolic Sympathetic Index 3 (DSI3) during Valsalva manoeuvre
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in Pressure Recovery Time (PRT) during Valsalva manoeuvre
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in Baroreceptor Reflex Sensitivity-adrenergic (BRS-a) during Valsalva manoeuvre
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in systolic latency during Valsalva manoeuvre
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in diastolic latency during Valsalva manoeuvre
timeFrame: Preoperatively, 6 and 24 hours postoperatively
Other outcomes:
measure: Pain score during mobilisation
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Estimated intraoperative bleeding
timeFrame: During surgery
measure: Intraoperative fluid balance
timeFrame: Intraoperative
measure: Surgery duration
timeFrame: Intraoperative
measure: Intraoperative propofol usage
timeFrame: Intraoperative
measure: Usage of cumulated opioids prior to mobilisation
timeFrame: Postoperatively
measure: Usage of Chlorzoxazone prior to mobilisation
timeFrame: Postoperatively
measure: Preoperative use of antihypertensives
timeFrame: Preoperatively
measure: Postoperative use of antihypertensives
timeFrame: Postoperatively
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre University Hospital
Study officials:
References:
citation: Jans O, Bundgaard-Nielsen M, Solgaard S, Johansson PI, Kehlet H. Orthostatic intolerance during early mobilization after fast-track hip arthroplasty. Br J Anaesth. 2012 Mar;108(3):436-43. doi: 10.1093/bja/aer403. Epub 2011 Dec 15.
citation: Jans O, Kehlet H. Postoperative orthostatic intolerance: a common perioperative problem with few available solutions. Can J Anaesth. 2017 Jan;64(1):10-15. doi: 10.1007/s12630-016-0734-7. Epub 2016 Sep 14. No abstract available.