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

C

Copenhagen University Hospital, Hvidovre

Status

Unknown

Conditions

Postoperative Complications
Orthostatic Intolerance
Orthostatic Hypotension

Treatments

Other: Standardized mobilization procedure

Study type

Observational

Funder types

Other

Identifiers

NCT04195360
H-19063289

Details and patient eligibility

About

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

Full 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.

Enrollment

42 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

42 participants in 2 patient groups

Orthostatic intolerant (OI)
Description:
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 mobilization
Treatment:
Other: Standardized mobilization procedure
Orthostatic tolerant (OT)
Description:
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 mobilization
Treatment:
Other: Standardized mobilization procedure

Trial contacts and locations

1

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Central trial contact

Louise Bundsgaard Andersen, medical student; Ana-Marija Hristovska, MD

Data sourced from clinicaltrials.gov

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