Postoperative Orthostatic Intolerance and Hypotension in Unilateral TKA
NCT ID: NCT03743116
Last Updated: 2022-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2018-11-13
2020-03-01
Brief Summary
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Detailed Description
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Previous prospective studies of major surgery have reported that OI and OH are common problem during early postoperative mobilization, with a prevalence of 42-50%. Retrospective studies with a less-defined mobilization protocols have reported am OI prevalence in the range of 12-60 % across surgical procedures.
The aim of our study is to determine the incidence of OI during early postoperative mobilization in fast track unilateral total knee arthroplasty.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Orthostatic intolerant (OI)
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
No interventions assigned to this group
Orthostatic tolerant (OT)
Patients that do not 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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
* Patients that speak and understand Danish
* Patients undergoing primary unilateral total knee arthroplasty in spinal anesthesia and standardized fast-track setting
Exclusion Criteria
* Cognitive dysfunction
* Known orthostatic hypotension
* Use of anxiolytic drugs
18 Years
100 Years
ALL
No
Sponsors
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Kehlet, Henrik, M.D., Ph.D.
INDIV
Hvidovre University Hospital
OTHER
Responsible Party
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Ana-Marija Hristovska
Principal Investigator, Medical Doctor
Principal Investigators
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Ana-Marija Hristovska, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology, Hvidovre Hospital, Copenhagen
Locations
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Hvidovre University Hosptial
Copenhagen, , Denmark
Countries
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Other Identifiers
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H-18049929
Identifier Type: -
Identifier Source: org_study_id
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