Postoperative Orthostatic Intolerance and Hypotension in Unilateral TKA

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Orthostatic Hypotension; Orthostatic Intolerance

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Hvidovre University Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing primary unilateral total knee arthroplasty in spinal anesthesia and standardized fast-track setting

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Orthostatic intolerant (OI); Patients that experience symptoms of orthostatic intolerance (dizziness, nausea, vomiting, blurry vision or syncope) or orthostatic hypotension (fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg) during mobilisation
Orthostatic tolerant (OT); Patients that do not experience symptoms of orthostatic intolerance (dizziness, nausea, vomiting, blurry vision or syncope) or orthostatic hypotension (fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg) during mobilisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of orthostatic intolerance	Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization	6 hours postoperatively
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in systolic arterial pressure (SAP) during mobilization	Measured in mmHg	Preoperatively, 6 and 24 hours postoperatively
Changes in diastolic arterial pressure (DAP) during mobilization	Measured in mmHg	Preoperatively, 6 and 24 hours postoperatively
Changes in mean arterial pressure (MAP) during mobilization	Measured in mmHg	Preoperatively, 6 and 24 hours postoperatively
Changes in systemic vascular resistance (SVR) during mobilization	Measured in mmHg⋅min⋅mL-1	Preoperatively, 6 and 24 hours postoperatively
Changes in cardiac output (CO) during mobilization	Measured in mL/min	Preoperatively, 6 and 24 hours postoperatively
Changes in stroke volume (SV) during mobilization	Measured in mL	Preoperatively, 6 and 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: Kehlet, Henrik, M.D., Ph.D.
• Investigators: Principal Investigator: Ana-Marija Hristovska, MD, Department of Anesthesiology, Hvidovre Hospital, Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2018
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Knee arthroplasty; Orthostatic Intolerance; Orthostatic Hypotension
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Neurologic Manifestations; Autonomic Nervous System Diseases; Primary Dysautonomias; Hypotension; Postoperative Complications; Hypotension, Orthostatic; Orthostatic Intolerance
• Other Study ID Numbers: H-18049929

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No