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Orthostatic Intolerance and Hypotension After Administration of Morphine in Patients Prior to Hip or Knee Arthroplasty

Conditions
Orthostatic Hypotension
Orthostatic Intolerance
Interventions
Registration Number
NCT04902222
Lead Sponsor
Copenhagen University Hospital, Hvidovre
Brief Summary

Incidence of orthostatic intolerance and orthostatic hypotension after intravenous administration of morphine in patients prior to hip or knee arthroplasty.

Detailed Description

Early postoperative mobilization is crucial for recovery of patients undergoing surgery in the multimodal fast-track approach to perioperative care, since physical immobilization is highly associated with increased risk of postoperative complications and prolonged hospital length of stay. Postoperative mobilization is often delayed due to patients experiencing orthostatic hypotension (OH), defined as a drop in systolic blood pressure \> 20 mmHg or diastolic blood pressure \> 10 mmHg, or orthostatic intolerance (OI), characterized by dizziness, blurred vision, nausea, vomiting, sensation of heat or syncope.

Previous studies have found a high incidence of postoperative OI (\> 40 %) among patients undergoing total hip arthroplasty.

A possible causative factor to the high occurrence of OH and OI after surgery could be postoperative pain management by administration of morphine. Morphine is known to have many side-effects including nausea, vomiting, dizziness and orthostatic hypotension.

The object of this study is to isolate and estimate the effect of intravenous morphine on the incidence of OH and OI.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
26
Inclusion Criteria
  • Patients undergoing primary unilateral total hip arthroplasty (THA), total knee arthroplasty (TKA) or unicompartmental knee arthroplasty (UKA)
  • Patients > 18
  • Patients that understand and speak Danish
  • Patients that have provided written informed consent
Exclusion Criteria
  • Alcohol or substance abuse
  • Habitual use of opioids
  • Habitual use of anxiolytic, antidepressant and/or antipsychotic drugs
  • History of previous orthostatic intolerance or hypotension
  • Cognitive dysfunction
  • Glomerular filtration rate (GFR) < 30 ml/min
  • Cardiac arrhythmia

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Patients undergoing primary hip or knee arthroplastyMorphinePatients undergoing primary hip or knee arthroplasty
Primary Outcome Measures
NameTimeMethod
Incidence of orthostatic hypotension30 minutes after morphine administration

Orthostatic hypotension is defined as a fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg during mobilization

Secondary Outcome Measures
NameTimeMethod
Changes in cardiac output (CO) during mobilizationBefore and 30 minutes after morphine administration

Measured in L/min by non-invasive LiDCO

Changes in mean arterial pressure (MAP) during mobilizationBefore and 30 minutes after morphine administration

Measured in mmHg by non-invasive LiDCO

Changes in systemic vascular resistance (SVR) during mobilizationBefore and 30 minutes after morphine administration

Measured in dynes s cm-5 by non-invasive LiDCO

Changes in cerebral perfusion (ScO2) during mobilizationBefore and 30 minutes after morphine administration

Measured in % by Root Masimo

Changes in heart rate variability (HRV) during Valsalva manoeuvreBefore and 30 minutes after morphine administration

Measured in ms

Changes in systolic arterial pressure (SAP) during mobilizationBefore and 30 minutes after morphine administration

Measured in mmHg by non-invasive Lithium Dilution Cardiac Output (LiDCO) measurement

Changes in peripheral perfusion index (PPI) during mobilizationBefore and 30 minutes after morphine administration

Measured in % by Root Masimo

Changes in baroreflex sensitivity - vagal (BRSv) during Valsalva manoeuvreBefore and 30 minutes after morphine administration

Measured in ms

Changes in heart rate (HR) during mobilizationBefore and 30 minutes after morphine administration

Measured in beats min-1 by non-invasive LiDCO

Changes in diastolic arterial pressure (DAP) during mobilizationBefore and 30 minutes after morphine administration

Measured in mmHg by non-invasive LiDCO

Changes in stroke volume (SV) during mobilizationBefore and 30 minutes after morphine administration

Measured in mL by non-invasive LiDCO

Changes in muscular perfusion (SmO2) during mobilizationBefore and 30 minutes after morphine administration

Measured in % by Root Masimo

Trial Locations

Locations (1)

Hvidovre University Hospital

🇩🇰

Hvidovre, Denmark

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