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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04195360
• Other study ID #: H-19063289
• Status: Recruiting
• Start date: December 2, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: December 2019
• Source: Copenhagen University Hospital, Hvidovre
• Contact: Louise Bundsgaard Andersen, medical student
• Phone: +45 41161599
• Email: louise.bundsgaard.andersen.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: May 1, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension
• Orthostatic Intolerance
• Postoperative Complications

Intervention

Other:
• Standardized mobilization procedure
5 minutes bed rest (h1), followed by 3 minutes passive leg raise (PLR), followed by 5 minutes bed rest (h2), followed by 3 minutes sitting on the egde of the bed (sit), followed by 3 minutes standing/walking on the spot (sta), followed by 5 minutes bedrest (h3)

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Copenhagen University Hospital, Hvidovre	Henrik Kehlet

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain score during mobilization	Measured by verbal rating scale (VRS) from 0 to 10	Preoperatively, 6 and 24 hours postoperatively
Other	Estimated bleeding	Measured in mL	Preoperatively, 6 and 24 hours postoperatively
Other	Opioid usage	Measured in mg	Preoperatively, 6 and 24 hours postoperatively
Other	Cumulative fluid administration and losses	Measured in mL	Preoperatively, 6 and 24 hours postoperatively
Primary	Incidence of orthostatic intolerance	Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization	6 hours postoperatively
Primary	Incidence of orthostatic hypotension	Orthostatic hypotension is defined as a fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg during mobilization	6 hours postoperatively
Secondary	Changes in systolic arterial pressure (SAP) during mobilization	Measured in mmHg, LiDCO-apparatus	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in diastolic arterial pressure (DAP) during mobilization	Measured in mmHg, LiDCO-apparatus	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in mean arterial pressure (MAP) during mobilization	Measured in mmHg, LiDCO-apparatus	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in cardiac output (CO) during mobilization	Measured in mL/min, LiDCO-apparatus	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in systemic vascular resistance (SVR) during mobilization	Measured in mmHg·min·mL-1	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in stroke volume (SV) during mobilization	Measured in mL, LiDCO-apparatus	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in heart rate variability (HRV) during mobilization	Measured in ms, LiDCO-apparatus	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in peripheral perfusion index (PPI) during mobilization	Measured in arbitrary units (AU), Massimo apparatus	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in cerebral perfusion (ScO2) during mobilization	Measured in %, NIRS-apparatus	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in muscular perfusion (SmO2) during mobilization	Measured in %, NIRS-apparatus	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in haemoglobin (Hgb) concentration	Measured in millimoles/L	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in C-Reactive Protein	Measured in mg/L	Preoperatively, 6 and 24 hours postoperatively