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

NCT04902222 | Unknown

• 1 other identifier: H-20071567
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Orthostatic Hypotension; Orthostatic Intolerance

Keywords

Orthostatic Hypotension; Orthostatic Intolerance; Morphine; Autonomic Dysfunction

Outcome Measures

Primary Outcomes (1)

• Incidence of orthostatic hypotension

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

  30 minutes after morphine administration

Secondary Outcomes (12)

• Changes in systolic arterial pressure (SAP) during mobilization

  Before and 30 minutes after morphine administration

• Changes in diastolic arterial pressure (DAP) during mobilization

  Before and 30 minutes after morphine administration

• Changes in mean arterial pressure (MAP) during mobilization

  Before and 30 minutes after morphine administration

• Changes in heart rate (HR) during mobilization

  Before and 30 minutes after morphine administration

• Changes in stroke volume (SV) during mobilization

  Before and 30 minutes after morphine administration

Other Outcomes (2)

• Pain score during mobilisation

  Before and 30 minutes after morphine administration

• Occurence of side-effects to morphine administration

  30 minutes after morphine administration

Study Arms (1)

Patients undergoing primary hip or knee arthroplasty

Patients undergoing primary hip or knee arthroplasty

Drug: Morphine

Interventions

Morphine DRUG

Administration of 0.1 mg/kg (IBW) intravenous morphine

Also known as: opioid

Patients undergoing primary hip or knee arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing primary unilateral total hip arthroplasty, total knee arthroplasty or unicompartmental knee arthroplasty

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2960, Denmark

RECRUITING

MeSH Terms

Conditions

Hypotension, Orthostatic; Orthostatic Intolerance; Primary Dysautonomias

Interventions

Morphine; Analgesics, Opioid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Nicolai Bang Foss, Dr. Med.

  Copenhagen University Hospital, Hvidovre

  STUDY DIRECTOR

Central Study Contacts

Bodil Uldall-Hansen, BA Medicine

CONTACT

+4528342057; bodil.uldall-hansen@regionh.dk

Ana-Marija Hristovska, Resident

CONTACT

+4538621508; anamarijahristovska@gmail.com

Study Design

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

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 26, 2021
• Study Start: April 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)