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Completed

NCT Number: NCT03743116

Postoperative Orthostatic Intolerance and Hypotension in Unilateral TKA

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

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Key information

Conditions

Orthostatic Intolerance Autonomic Nervous System Diseases Cardiovascular Diseases Hypotension Hypotension, Orthostatic Nervous System Diseases Neurologic Manifestations Orthostatic Hypotension Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Primary Dysautonomias Signs and Symptoms Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hvidovre University Hosptial

Copenhagen, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of orthostatic intolerance

    Time frame: 6 hours postoperatively

    Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization

  2. 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 outcomes

  1. Changes in systolic arterial pressure (SAP) during mobilization

    Time frame: Preoperatively, 6 and 24 hours postoperatively

    Measured in mmHg

  2. Changes in diastolic arterial pressure (DAP) during mobilization

    Time frame: Preoperatively, 6 and 24 hours postoperatively

    Measured in mmHg

  3. Changes in mean arterial pressure (MAP) during mobilization

    Time frame: Preoperatively, 6 and 24 hours postoperatively

    Measured in mmHg

  4. Changes in systemic vascular resistance (SVR) during mobilization

    Time frame: Preoperatively, 6 and 24 hours postoperatively

    Measured in mmHg⋅min⋅mL-1

  5. Changes in cardiac output (CO) during mobilization

    Time frame: Preoperatively, 6 and 24 hours postoperatively

    Measured in mL/min

  6. Changes in stroke volume (SV) during mobilization

    Time frame: Preoperatively, 6 and 24 hours postoperatively

    Measured in mL

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Kehlet, Henrik, M.D., Ph.D.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 15, 2018
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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