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Postoperative Orthostatic Intolerance and Hypotension in Unilateral TKA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743116
Recruitment Status : Active, not recruiting
First Posted : November 15, 2018
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
Henrik Kehlet
Information provided by (Responsible Party):
Ana-Marija Hristovska, Hvidovre University Hospital

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

Condition or disease
Orthostatic Intolerance Orthostatic Hypotension Postoperative Complications

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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Postoperative Orthostatic Intolerance and Postoperative Orthostatic Hypotension in Patients Undergoing Unilateral Total Knee Arthroplasty
Actual Study Start Date : November 13, 2018
Actual Primary Completion Date : July 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing primary unilateral total knee arthroplasty in spinal anesthesia and standardized fast-track setting
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743116


Locations
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Denmark
Hvidovre University Hosptial
Copenhagen, Denmark
Sponsors and Collaborators
Hvidovre University Hospital
Henrik Kehlet
Investigators
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Principal Investigator: Ana-Marija Hristovska, MD Department of Anesthesiology, Hvidovre Hospital, Copenhagen
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Responsible Party: Ana-Marija Hristovska, Principal Investigator, Medical Doctor, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT03743116    
Other Study ID Numbers: H-18049929
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana-Marija Hristovska, Hvidovre University Hospital:
Orthostatic Intolerance
Orthostatic Hypotension
Knee arthroplasty
Additional relevant MeSH terms:
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Hypotension, Orthostatic
Orthostatic Intolerance
Hypotension
Postoperative Complications
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms