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Postoperative Incidence of Orthostatic Intolerance and Hypotension in Primary Unicompartmental Knee Arthroplasty (UKA)

Postoperative Incidence of Orthostatic Intolerance and Hypotension in Patients Undergoing Primary Unicompartmental Knee Arthroplasty (UKA)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04195360
Enrollment
42
Registered
2019-12-11
Start date
2019-12-02
Completion date
2020-05-01
Last updated
2019-12-13

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

Conditions

Orthostatic Hypotension, Orthostatic Intolerance, Postoperative Complications

Brief summary

Incidence and pathophysiologic hemodynamics of orthostatic intolerance and orthostatic hypotension in patients undergoing UKA

Detailed description

In today's multimodal fast-track perioperative care program (ERAS) early mobilization is an essential cornerstone, and is known to prevent postoperative morbidity and lower length of stay in the hospital. Intact orthostatic blood pressure regulation is necessary to complete mobilization, and postoperative orthostatic hypotension (OH), defined as a drop in systolic arterial pressure (SAP) \> 20 mmHg or a drop \>10 mmHg in diastolic arterial pressure (DAP) and orthostatic intolerance (OI), characterized by dizziness, nausea, feeling warm and syncope related to orthostatic challenge, are well-known reasons for delayed early mobilization, prolonged bedrest and delayed ambulation. Former studies have been accessing the postoperative incidence in THA-patients (22%-40%), TKA-patients(36%), colorectal patients(53%), abdominal and cardiothoracic surgery patients(40%), radical prostatectomy patients (50%). One study have been accessing the postoperative incidence of OI in mastectomy patients and found an incidence of 4%, and thereby indicating that postoperative OI is not an issue in minor surgery. This study is the first, to our acknowledgement, which accesses the postoperative incidence of OI/OH in UKA-patients.

Interventions

OTHERStandardized mobilization procedure

5 minutes bed rest (h1), followed by 3 minutes passive leg raise (PLR), followed by 5 minutes bed rest (h2), followed by 3 minutes sitting on the egde of the bed (sit), followed by 3 minutes standing/walking on the spot (sta), followed by 5 minutes bedrest (h3)

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \>18 years and * Patients undergoing UKA in spinal anesthesia at Hvidovre Hospital in a standardized fast-track setting. * Patients that speak and understand Danish * Written informed consent

Exclusion criteria

* Pre-existing orthostatic hypotension or intolerance * Alcohol or substance abuse * everyday treatment with either anxiolytic or antipsychotic medicine * Cognitive dysfunction * If surgery was converted to general anesthesia or total knee arthroplasty.

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 systemic vascular resistance (SVR) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in mmHg⋅min⋅mL-1
Changes in cerebral perfusion (ScO2) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in %, NIRS-apparatus
Changes in muscular perfusion (SmO2) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in %, NIRS-apparatus
Changes in haemoglobin (Hgb) concentrationPreoperatively, 6 and 24 hours postoperativelyMeasured in millimoles/L
Changes in C-Reactive ProteinPreoperatively, 6 and 24 hours postoperativelyMeasured in mg/L
Changes in stroke volume (SV) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in mL, LiDCO-apparatus
Changes in systolic arterial pressure (SAP) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in mmHg, LiDCO-apparatus
Changes in diastolic arterial pressure (DAP) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in mmHg, LiDCO-apparatus
Changes in mean arterial pressure (MAP) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in mmHg, LiDCO-apparatus
Changes in cardiac output (CO) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in mL/min, LiDCO-apparatus
Changes in heart rate variability (HRV) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in ms, LiDCO-apparatus
Changes in peripheral perfusion index (PPI) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in arbitrary units (AU), Massimo apparatus

Other

MeasureTime frameDescription
Cumulative fluid administration and lossesPreoperatively, 6 and 24 hours postoperativelyMeasured in mL
Opioid usagePreoperatively, 6 and 24 hours postoperativelyMeasured in mg
Estimated bleedingPreoperatively, 6 and 24 hours postoperativelyMeasured in mL
Pain score during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured by verbal rating scale (VRS) from 0 to 10

Countries

Denmark

Contacts

Primary ContactLouise Bundsgaard Andersen, medical student
louise.bundsgaard.andersen.01@regionh.dk+45 41161599
Backup ContactAna-Marija Hristovska, MD
ana-marija.hristovska.02@regionh.dk+4538621508

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026