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Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty in Patients Receiving ACEIs and ARBs

Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty in Patients Receiving Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin II Receptor Blockers (ARBs)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04842058
Enrollment
24
Registered
2021-04-12
Start date
2020-12-01
Completion date
2023-12-01
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthostatic Hypotension, Orthostatic Intolerance

Keywords

Orthostatic Hypotension, Orthostatic Intolerance, Postoperative period, Antihypertensives, Autonomic dysfunction

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.

Interventions

OTHERMobilisation procedure

A standardized mobilization procedure was performed preoperatively \ 1h before surgery and was repeated 6h and 24h after surgery. The mobilization procedure included patient supine rest (5 minutes), followed by 45° passive leg raise (PLR) (3 minutes), supine rest (5 minutes), sitting on the edge of the bed with feet resting on the floor (3 minutes) followed by standing using a walker while the patient was encouraged verbally to stand on toes and shift body weight from one leg to the other (3 minutes) and finally rest in supine position (5 minutes). The procedure was terminated prematurely in any position if patients experienced unbearable symptoms of OI or upon a decrease of systolic arterial pressure (SAP) \> 30 mmHg.

Sponsors

Kehlet, Henrik, M.D., Ph.D.
CollaboratorINDIV
Hvidovre University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of orthostatic intolerance6 hours postoperativelySymptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization
Incidence of orthostatic hypotension6 hours postoperativelyOrthostatic hypotension is defined as a fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg during mobilization

Secondary

MeasureTime frameDescription
Changes in Pressure Recovery Time (PRT) during Valsalva manoeuvrePreoperatively, 6 and 24 hours postoperativelyMeasured in seconds
Changes in Systolic Sympathetic Index 1 (SSI1) during Valsalva manoeuvrePreoperatively, 6 and 24 hours postoperativelyMeasured as index
Changes in Systolic Sympathetic Index 2 (SSI2) during Valsalva manoeuvrePreoperatively, 6 and 24 hours postoperativelyMeasured as index
Changes in Systolic Sympathetic Index 3 (SSI3) during Valsalva manoeuvrePreoperatively, 6 and 24 hours postoperativelyMeasured as index
Changes in Diastolic Sympathetic Index 1 (DSI1) during Valsalva manoeuvrePreoperatively, 6 and 24 hours postoperativelyMeasured as index
Changes in Diastolic Sympathetic Index 2 (DSI2) during Valsalva manoeuvrePreoperatively, 6 and 24 hours postoperativelyMeasured as index
Changes in Diastolic Sympathetic Index 3 (DSI3) during Valsalva manoeuvrePreoperatively, 6 and 24 hours postoperativelyMeasured as index
Changes in Baroreceptor Reflex Sensitivity-adrenergic (BRS-a) during Valsalva manoeuvrePreoperatively, 6 and 24 hours postoperativelyMeasured in seconds
Changes in systolic latency during Valsalva manoeuvrePreoperatively, 6 and 24 hours postoperativelyMeasured in seconds
Changes in diastolic latency during Valsalva manoeuvrePreoperatively, 6 and 24 hours postoperativelyMeasured in seconds
Changes in systolic arterial pressure (SAP) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in mmHg by non-invasive Lithium Dilution Cardiac Output (LiDCO) measurement
Changes in diastolic arterial pressure (DAP) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in mmHg by non-invasive LiDCO
Changes in mean arterial pressure (MAP) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in mmHg by non-invasive LiDCO
Changes in systemic vascular resistance (SVR) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in dynes s cm-5 by non-invasive LiDCO
Changes in cardiac output (CO) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in L/min by non-invasive LiDCO
Changes in stroke volume (SV) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in mL by non-invasive LiDCO
Changes in heart rate (HR) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in beats min-1 by non-invasive LiDCO
Changes in pulse pressure (PP) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in mmHg
Changes in cerebral perfusion (ScO2) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in % by Root Masimo
Changes in muscular perfusion (SmO2) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in % by Root Masimo
Changes in peripheral perfusion index (PPI) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in % by Root Masimo
Changes in total blood volume (TBV)Preoperatively, 6 and 24 hours postoperativelyMeasured in mL by Carbon Monoxide - rebreathing technique
Changes in red blood cell volume (RBCV)Preoperatively, 6 and 24 hours postoperativelyMeasured in mL by Carbon Monoxide - rebreathing technique
Changes in plasma volume (PV)Preoperatively, 6 and 24 hours postoperativelyMeasured in mL by Carbon Monoxide - rebreathing technique
Changes in hematocritPreoperatively, 6 and 24 hours postoperativelyMeasured in %
Changes in total mass of hemoglobinPreoperatively, 6 and 24 hours postoperativelyMeasured in grams
Changes in hemoglobin concentrationPreoperatively, 6 and 24 hours postoperativelyMeasured in gr/L
Changes in C-Reactive ProteinPreoperatively, 6 and 24 hours postoperativelyMeasured in mg/L
Changes in heart rate variability (HRV) during Valsalva manoeuvrePreoperatively, 6 and 24 hours postoperativelyMeasured in ms
Changes in baroreflex sensitivity - vagal (BRSv) during Valsalva manoeuvrePreoperatively, 6 and 24 hours postoperativelyMeasured in ms
Changes in Valsalva ratio (VR) during Valsalva manoeuvrePreoperatively, 6 and 24 hours postoperativelyMeasured as index

Other

MeasureTime frameDescription
Surgery durationIntraoperativeMinutes
Intraoperative propofol usageIntraoperativeMg
Usage of cumulated opioids prior to mobilisationPostoperativelymg
Usage of Chlorzoxazone prior to mobilisationPostoperativelymg
Preoperative use of antihypertensivesPreoperativelyType, dose and time of administration
Postoperative use of antihypertensivesPostoperativelyType, dose and time of administration
Pain score during mobilisationPreoperatively, 6 and 24 hours postoperativelyMeasured by verbal rating scale (VRS) from 0 to 10 (0 = no pain, 10 = worse pain imaginable)
Estimated intraoperative bleedingDuring surgeryMeasured in mL
Intraoperative fluid balanceIntraoperativeMeasured in mL

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026