Postoperative Incidence of Orthostatic Intolerance and Hypotension in Primary Unicompartmental Knee Arthroplasty (UKA)

NCT04195360 | Unknown

• 1 other identifier: H-19063289
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Incidence and pathophysiologic hemodynamics of orthostatic intolerance and orthostatic hypotension in patients undergoing UKA

Conditions

Orthostatic Hypotension; Orthostatic Intolerance; Postoperative Complications

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 (12)

• 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 cardiac output (CO) during mobilization

  Preoperatively, 6 and 24 hours postoperatively

• Changes in systemic vascular resistance (SVR) during mobilization

  Preoperatively, 6 and 24 hours postoperatively

Other Outcomes (4)

• Pain score during mobilization

  Preoperatively, 6 and 24 hours postoperatively

• Estimated bleeding

  Preoperatively, 6 and 24 hours postoperatively

• Opioid usage

  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 mobilization

Other: Standardized mobilization procedure

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 mobilization

Other: Standardized mobilization procedure

Interventions

Standardized mobilization procedure OTHER

5 minutes bed rest (h1), followed by 3 minutes passive leg raise (PLR), followed by 5 minutes bed rest (h2), followed by 3 minutes sitting on the egde of the bed (sit), followed by 3 minutes standing/walking on the spot (sta), followed by 5 minutes bedrest (h3)

Orthostatic intolerant (OI); Orthostatic tolerant (OT)

Eligibility Criteria

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

Study Population

Patients were screened in the electronic patient system, and were first screened for inclusion criteria, and afterwards exclusion criteria. Patients were eligible to enroll in the study if they were \>18 years, spoke and understood Danish, signed an informed consent formula and underwent UKA in spinal anesthesia at Hvidovre Hospital. They were excluded if they had 1) pre-existing orthostatic hypotension or intolerance, 2) Alcohol or substance abuse, 3) everyday treatment with either anxiolytic or antipsychotic medicine 4) Cognitive dysfunction. 5) Or if surgery was converted to general anesthesia or total knee arthroplasty.

You may qualify if:

• Age \>18 years and
• Patients undergoing UKA in spinal anesthesia at Hvidovre Hospital in a standardized fast-track setting.
• Patients that speak and understand Danish
• Written informed consent

You may not qualify if:

• Pre-existing orthostatic hypotension or intolerance
• Alcohol or substance abuse
• everyday treatment with either anxiolytic or antipsychotic medicine
• Cognitive dysfunction
• If surgery was converted to general anesthesia or total knee arthroplasty.

Sponsors & Collaborators

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

Study Sites (1)

Hvidovre Hospital

Hvidovre, 2650, Denmark

RECRUITING

Related Publications (1)

• Hristovska AM, Andersen LB, Uldall-Hansen B, Kehlet H, Troelsen A, Gromov K, Foss NB. Postoperative orthostatic intolerance following fast-track unicompartmental knee arthroplasty: incidence and hemodynamics-a prospective observational cohort study. J Orthop Surg Res. 2024 Apr 1;19(1):214. doi: 10.1186/s13018-024-04639-6.

  PMID: 38561817 DERIVED

MeSH Terms

Conditions

Hypotension, Orthostatic; Orthostatic Intolerance; Postoperative Complications

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Louise Bundsgaard Andersen, medical student

CONTACT

+45 41161599; louise.bundsgaard.andersen.01@regionh.dk

Ana-Marija Hristovska, MD

CONTACT

+4538621508; ana-marija.hristovska.02@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Undergraduate Student

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 11, 2019
• Study Start: December 2, 2019
• Primary Completion: March 31, 2020
• Study Completion: May 1, 2020
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)