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

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Brief Title

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

Official Title

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

Brief Summary

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

Detailed 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.

Study Type

Observational

Primary Outcome

Incidence of orthostatic intolerance

Secondary Outcome

 Changes in systolic arterial pressure (SAP) during mobilization

Condition

Orthostatic Hypotension

Intervention

Standardized mobilization procedure

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 mobilization

Publications

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

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

42

Start Date

December 2, 2019

Completion Date

May 1, 2020

Primary Completion Date

March 31, 2020

Eligibility Criteria

        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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, +45 41161599, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations

NCT ID

NCT04195360

Organization ID

H-19063289

Responsible Party

Principal Investigator

Study Sponsor

Copenhagen University Hospital, Hvidovre

Collaborators

 Kehlet, Henrik, M.D., Ph.D.

Study Sponsor

, ,

Verification Date

December 2019