Clinical trial NCT04195360: 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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Orthostatic Hypotension
Orthostatic Intolerance
Postoperative Complications
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
Collaborators: name: Kehlet, Henrik, M.D., Ph.D.
First posted: 2019-12-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were screened in the electronic patient system, and were first screened for inclusion criteria, and afterwards exclusion criteria.

Patients were eligible to enroll in the study if they were \>18 years, spoke and understood Danish, signed an informed consent formula and underwent UKA in spinal anesthesia at Hvidovre Hospital. They were excluded if they had 1) pre-existing orthostatic hypotension or intolerance, 2) Alcohol or substance abuse, 3) everyday treatment with either anxiolytic or antipsychotic medicine 4) Cognitive dysfunction. 5) Or if surgery was converted to general anesthesia or total knee arthroplasty.

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.

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.

Primary outcomes:
measure: Incidence of orthostatic intolerance
timeFrame: 6 hours postoperatively
measure: Incidence of orthostatic hypotension
timeFrame: 6 hours postoperatively
Secondary outcomes:
measure: Changes in systolic arterial pressure (SAP) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in diastolic arterial pressure (DAP) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in mean arterial pressure (MAP) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in cardiac output (CO) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in systemic vascular resistance (SVR) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in stroke volume (SV) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in heart rate variability (HRV) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in peripheral perfusion index (PPI) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in cerebral perfusion (ScO2) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in muscular perfusion (SmO2) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in haemoglobin (Hgb) concentration
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in C-Reactive Protein
timeFrame: Preoperatively, 6 and 24 hours postoperatively
Other outcomes:
measure: Pain score during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Estimated bleeding
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Opioid usage
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Cumulative fluid administration and losses
timeFrame: Preoperatively, 6 and 24 hours postoperatively
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
References: