Postoperative Orthostatic Intolerance and Hypotension in Unilateral TKA

Brief Title

Postoperative Orthostatic Intolerance and Hypotension in Unilateral TKA

Official Title

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

Brief Summary

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

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.
    


Study Type

Observational


Primary Outcome

Incidence of orthostatic intolerance

Secondary Outcome

 Changes in systolic arterial pressure (SAP) during mobilization

Condition

Orthostatic Intolerance


Study Arms / Comparison 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 mobilisation

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

50

Start Date

November 13, 2018

Completion Date

March 1, 2020

Primary Completion Date

July 1, 2019

Eligibility 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
      

Gender

All

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Ana-Marija Hristovska, MD, , 

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT03743116

Organization ID

H-18049929


Responsible Party

Principal Investigator

Study Sponsor

Hvidovre University Hospital

Collaborators

 Henrik Kehlet

Study Sponsor

Ana-Marija Hristovska, MD, Principal Investigator, Department of Anesthesiology, Hvidovre Hospital, Copenhagen


Verification Date

January 2020