Postoperative Orthostatic Intolerance and Hypotension in Unilateral TKA

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03743116
• Other study ID #: H-18049929
• Status: Completed
• Start date: November 13, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: August 2022
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 1, 2020
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Denmark	Hvidovre University Hosptial	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Kehlet, Henrik, M.D., Ph.D.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in diastolic arterial pressure (DAP) during mobilization	Measured in mmHg	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in mean arterial pressure (MAP) during mobilization	Measured in mmHg	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 cardiac output (CO) during mobilization	Measured in mL/min	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in stroke volume (SV) during mobilization	Measured in mL	Preoperatively, 6 and 24 hours postoperatively