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
Henrik Kehlet
Study Sponsor
, ,
Verification Date
December 2019