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

• Conditions: Orthostatic Intolerance; Postoperative Complications; Orthostatic Hypotension
• Interventions: Other: Standardized mobilization procedure

• Registration Number: NCT04195360
• Lead Sponsor: Copenhagen University Hospital, Hvidovre

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 Timeline

• Status Verified: 2019-12
• Study Start: 2019-12-02
• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-11
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-13
• Primary Completion: 2020-03-31
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Orthostatic intolerant (OI)	Standardized mobilization procedure	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
Orthostatic tolerant (OT)	Standardized mobilization procedure	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 mobilization

Primary Outcome Measures

Name	Time	Method
Incidence of orthostatic intolerance	6 hours postoperatively	Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization
Incidence of orthostatic hypotension	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

Name	Time	Method
Changes in systolic arterial pressure (SAP) during mobilization	Preoperatively, 6 and 24 hours postoperatively	Measured in mmHg, LiDCO-apparatus
Changes in diastolic arterial pressure (DAP) during mobilization	Preoperatively, 6 and 24 hours postoperatively	Measured in mmHg, LiDCO-apparatus
Changes in mean arterial pressure (MAP) during mobilization	Preoperatively, 6 and 24 hours postoperatively	Measured in mmHg, LiDCO-apparatus
Changes in cardiac output (CO) during mobilization	Preoperatively, 6 and 24 hours postoperatively	Measured in mL/min, LiDCO-apparatus
Changes in systemic vascular resistance (SVR) during mobilization	Preoperatively, 6 and 24 hours postoperatively	Measured in mmHg⋅min⋅mL-1
Changes in stroke volume (SV) during mobilization	Preoperatively, 6 and 24 hours postoperatively	Measured in mL, LiDCO-apparatus
Changes in heart rate variability (HRV) during mobilization	Preoperatively, 6 and 24 hours postoperatively	Measured in ms, LiDCO-apparatus
Changes in peripheral perfusion index (PPI) during mobilization	Preoperatively, 6 and 24 hours postoperatively	Measured in arbitrary units (AU), Massimo apparatus
Changes in cerebral perfusion (ScO2) during mobilization	Preoperatively, 6 and 24 hours postoperatively	Measured in %, NIRS-apparatus
Changes in muscular perfusion (SmO2) during mobilization	Preoperatively, 6 and 24 hours postoperatively	Measured in %, NIRS-apparatus
Changes in haemoglobin (Hgb) concentration	Preoperatively, 6 and 24 hours postoperatively	Measured in millimoles/L
Changes in C-Reactive Protein	Preoperatively, 6 and 24 hours postoperatively	Measured in mg/L

Trial Locations

Locations (1)

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark