Clinical trial NCT03743116: Postoperative Orthostatic Intolerance and Hypotension in Unilateral TKA
Official title: Incidence of Postoperative Orthostatic Intolerance and Postoperative Orthostatic Hypotension in Patients Undergoing Unilateral Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthostatic Intolerance
Orthostatic Hypotension
Postoperative Complications
Keywords: Orthostatic Intolerance
Orthostatic Hypotension
Knee arthroplasty
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Kehlet, Henrik, M.D., Ph.D.
First posted: 2018-11-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing primary unilateral total knee arthroplasty in spinal anesthesia and standardized fast-track setting

Brief summary: Incidence of Postoperative Orthostatic Intolerance and Postoperative Orthostatic Hypotension in Patients Undergoing Unilateral Total Knee Arthroplasty

Detailed description: Early postoperative mobilization is a cornerstone in the so-called fast track multimodal perioperative approach and is essential in preventing postoperative morbidity and reducing hospital length-of-stay. Intact orthostatic blood pressure regulation is essential for early postoperative mobilization. However, early postoperative mobilization can be delayed due to postoperative orthostatic hypotension (POH) defined as a fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg or due to postoperative orthostatic intolerance (POI), characterized by dizziness, nausea, vomiting, blurred vision or syncope during mobilization.

Previous prospective studies of major surgery have reported that OI and OH are common problem during early postoperative mobilization, with a prevalence of 42-50%. Retrospective studies with a less-defined mobilization protocols have reported am OI prevalence in the range of 12-60 % across surgical procedures.

The aim of our study is to determine the incidence of OI during early postoperative mobilization in fast track unilateral total knee arthroplasty.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Written informed consent
* Patients that speak and understand Danish
* Patients undergoing primary unilateral total knee arthroplasty in spinal anesthesia and standardized fast-track setting

Exclusion Criteria:

* Alcohol or drug abuse
* Cognitive dysfunction
* Known orthostatic hypotension
* Use of anxiolytic drugs

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 systemic vascular resistance (SVR) 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 stroke volume (SV) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre University Hosptial
Study officials:
affiliation: Department of Anesthesiology, Hvidovre Hospital, Copenhagen
name: Ana-Marija Hristovska, MD
role: PRINCIPAL_INVESTIGATOR
References: