Postoperative Orthostatic Intolerance and Hypotension in Unilateral TKA

NCT03743116 | Completed DMC

• 1 other identifier: H-18049929
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Orthostatic Intolerance; Orthostatic Hypotension; Postoperative Complications

Keywords

Orthostatic Intolerance; Orthostatic Hypotension; Knee arthroplasty

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Changes in systolic arterial pressure (SAP) during mobilization

  Preoperatively, 6 and 24 hours postoperatively

• Changes in diastolic arterial pressure (DAP) during mobilization

  Preoperatively, 6 and 24 hours postoperatively

• Changes in mean arterial pressure (MAP) during mobilization

  Preoperatively, 6 and 24 hours postoperatively

• Changes in systemic vascular resistance (SVR) during mobilization

  Preoperatively, 6 and 24 hours postoperatively

• Changes in cardiac output (CO) during mobilization

  Preoperatively, 6 and 24 hours postoperatively

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Kehlet, Henrik, M.D., Ph.D.: collaborator

Study Sites (1)

Hvidovre University Hosptial

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Orthostatic Intolerance; Hypotension, Orthostatic; Postoperative Complications

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypotension; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes

Study Officials

• Ana-Marija Hristovska, MD

  Department of Anesthesiology, Hvidovre Hospital, Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Medical Doctor

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 15, 2018
• Study Start: November 13, 2018
• Primary Completion: July 1, 2019
• Study Completion: March 1, 2020
• Last Updated: August 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)