Postoperative Orthostatic Intolerance and Hypotension in Unilateral TKA

Completed

• Conditions: Orthostatic Intolerance; Orthostatic Hypotension; Postoperative Complications

• Registration Number: NCT03743116
• Lead Sponsor: Hvidovre University Hospital

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.

Study Timeline

• Study First Submitted: 2018-11-08
• Study Start: 2018-11-13
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-15
• Primary Completion: 2019-07-01
• Study Completion: 2020-03-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Changes in mean arterial pressure (MAP) during mobilization	Preoperatively, 6 and 24 hours postoperatively	Measured in mmHg
Changes in diastolic arterial pressure (DAP) during mobilization	Preoperatively, 6 and 24 hours postoperatively	Measured in mmHg
Changes in cardiac output (CO) during mobilization	Preoperatively, 6 and 24 hours postoperatively	Measured in mL/min
Changes in systolic arterial pressure (SAP) during mobilization	Preoperatively, 6 and 24 hours postoperatively	Measured in mmHg

Trial Locations

Locations (1)

Hvidovre University Hosptial; 🇩🇰 Copenhagen, Denmark