Postoperative Orthostatic Intolerance and Hypotension in Unilateral TKA

Overview

Incidence of Postoperative Orthostatic Intolerance and Postoperative Orthostatic Hypotension in Patients Undergoing Unilateral Total Knee Arthroplasty

Full Title of Study: “Incidence of Postoperative Orthostatic Intolerance and Postoperative Orthostatic Hypotension in Patients Undergoing Unilateral Total Knee Arthroplasty”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 1, 2019

Detailed Description

Early postoperative mobilization is a cornerstone in the so-called fast track multimodal perioperative approach and is essential in preventing postoperative morbidity and reducing hospital length-of-stay. Intact orthostatic blood pressure regulation is essential for early postoperative mobilization. However, early postoperative mobilization can be delayed due to postoperative orthostatic hypotension (POH) defined as a fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg or due to postoperative orthostatic intolerance (POI), characterized by dizziness, nausea, vomiting, blurred vision or syncope during mobilization. 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.

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of orthostatic intolerance
    • Time Frame: 6 hours postoperatively
    • Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization
  • Incidence of orthostatic hypotension
    • Time Frame: 6 hours postoperatively
    • Orthostatic hypotension is defined as a fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg during mobilization

Secondary Measures

  • Changes in systolic arterial pressure (SAP) during mobilization
    • Time Frame: Preoperatively, 6 and 24 hours postoperatively
    • Measured in mmHg
  • Changes in diastolic arterial pressure (DAP) during mobilization
    • Time Frame: Preoperatively, 6 and 24 hours postoperatively
    • Measured in mmHg
  • Changes in mean arterial pressure (MAP) during mobilization
    • Time Frame: Preoperatively, 6 and 24 hours postoperatively
    • Measured in mmHg
  • Changes in systemic vascular resistance (SVR) during mobilization
    • Time Frame: Preoperatively, 6 and 24 hours postoperatively
    • Measured in mmHg⋅min⋅mL-1
  • Changes in cardiac output (CO) during mobilization
    • Time Frame: Preoperatively, 6 and 24 hours postoperatively
    • Measured in mL/min
  • Changes in stroke volume (SV) during mobilization
    • Time Frame: Preoperatively, 6 and 24 hours postoperatively
    • Measured in mL

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥ 18 – 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:

  • Alcohol or drug abuse – Cognitive dysfunction – Known orthostatic hypotension – Use of anxiolytic drugs

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hvidovre University Hospital
  • Collaborator
    • Kehlet, Henrik, M.D., Ph.D.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ana-Marija Hristovska, Principal Investigator, Medical Doctor – Hvidovre University Hospital
  • Overall Official(s)
    • Ana-Marija Hristovska, MD, Principal Investigator, Department of Anesthesiology, Hvidovre Hospital, Copenhagen

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