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

Orthostatic Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04842058
• Other study ID #: H-20017723
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: April 2021
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Incidence and pathophysiologic hemodynamics of postoperative orthostatic intolerance and orthostatic hypotension in patients receiving antihypertensives

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 information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension
• Orthostatic Intolerance

Intervention

Other:
• Mobilisation 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.

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Henrik Kehlet

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Jans Ø, 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. — View Citation

Jans Ø, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain score during mobilisation	Measured by verbal rating scale (VRS) from 0 to 10 (0 = no pain, 10 = worse pain imaginable)	Preoperatively, 6 and 24 hours postoperatively
Other	Estimated intraoperative bleeding	Measured in mL	During surgery
Other	Intraoperative fluid balance	Measured in mL	Intraoperative
Other	Surgery duration	Minutes	Intraoperative
Other	Intraoperative propofol usage	Mg	Intraoperative
Other	Usage of cumulated opioids prior to mobilisation	mg	Postoperatively
Other	Usage of Chlorzoxazone prior to mobilisation	mg	Postoperatively
Other	Preoperative use of antihypertensives	Type, dose and time of administration	Preoperatively
Other	Postoperative use of antihypertensives	Type, dose and time of administration	Postoperatively
Primary	Incidence of orthostatic intolerance	Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization	6 hours postoperatively
Primary	Incidence of orthostatic hypotension	Orthostatic hypotension is defined as a fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg during mobilization	6 hours postoperatively
Secondary	Changes in systolic arterial pressure (SAP) during mobilization	Measured in mmHg by non-invasive Lithium Dilution Cardiac Output (LiDCO) measurement	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in diastolic arterial pressure (DAP) during mobilization	Measured in mmHg by non-invasive LiDCO	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in mean arterial pressure (MAP) during mobilization	Measured in mmHg by non-invasive LiDCO	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in systemic vascular resistance (SVR) during mobilization	Measured in dynes s cm-5 by non-invasive LiDCO	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in cardiac output (CO) during mobilization	Measured in L/min by non-invasive LiDCO	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in stroke volume (SV) during mobilization	Measured in mL by non-invasive LiDCO	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in heart rate (HR) during mobilization	Measured in beats min-1 by non-invasive LiDCO	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in pulse pressure (PP) during mobilization	Measured in mmHg	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in cerebral perfusion (ScO2) during mobilization	Measured in % by Root Masimo	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in muscular perfusion (SmO2) during mobilization	Measured in % by Root Masimo	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in peripheral perfusion index (PPI) during mobilization	Measured in % by Root Masimo	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in total blood volume (TBV)	Measured in mL by Carbon Monoxide - rebreathing technique	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in red blood cell volume (RBCV)	Measured in mL by Carbon Monoxide - rebreathing technique	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in plasma volume (PV)	Measured in mL by Carbon Monoxide - rebreathing technique	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in hematocrit	Measured in %	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in total mass of hemoglobin	Measured in grams	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in hemoglobin concentration	Measured in gr/L	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in C-Reactive Protein	Measured in mg/L	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in heart rate variability (HRV) during Valsalva manoeuvre	Measured in ms	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in baroreflex sensitivity - vagal (BRSv) during Valsalva manoeuvre	Measured in ms	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in Valsalva ratio (VR) during Valsalva manoeuvre	Measured as index	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in Systolic Sympathetic Index 1 (SSI1) during Valsalva manoeuvre	Measured as index	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in Systolic Sympathetic Index 2 (SSI2) during Valsalva manoeuvre	Measured as index	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in Systolic Sympathetic Index 3 (SSI3) during Valsalva manoeuvre	Measured as index	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in Diastolic Sympathetic Index 1 (DSI1) during Valsalva manoeuvre	Measured as index	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in Diastolic Sympathetic Index 2 (DSI2) during Valsalva manoeuvre	Measured as index	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in Diastolic Sympathetic Index 3 (DSI3) during Valsalva manoeuvre	Measured as index	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in Pressure Recovery Time (PRT) during Valsalva manoeuvre	Measured in seconds	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in Baroreceptor Reflex Sensitivity-adrenergic (BRS-a) during Valsalva manoeuvre	Measured in seconds	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in systolic latency during Valsalva manoeuvre	Measured in seconds	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in diastolic latency during Valsalva manoeuvre	Measured in seconds	Preoperatively, 6 and 24 hours postoperatively