Orthostatic HypotensionNCT04902222
Orthostatic Intolerance and Hypotension After Administration of Morphine in Patients Prior to Hip or Knee Arthroplasty
An observational study of Orthostatic Hypotension and Orthostatic Intolerance, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial summary
Incidence of orthostatic intolerance and orthostatic hypotension after intravenous administration of morphine in patients prior to hip or knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthostatic Hypotension, Orthostatic Intolerance
- What is being tested?
- Morphine
- Type of treatment
- Injection or infusion
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2021to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients undergoing primary unilateral total hip arthroplasty, total knee arthroplasty or unicompartmental knee arthroplasty
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Hvidovre University Hospital
Hvidovre, 2960
Bodil Uldall-Hansen, BA Medicine, +4528342057, bodil.uldall-hansen@regionh.dk
Ana-Marija Hristovska, Resident, +4538621508, anamarijahristovska@gmail.com
About this study
Official title: Incidence of Orthostatic Intolerance and Orthostatic Hypotension After Administration of Intravenous Morphine in Patients Prior to Hip or Knee Arthroplasty
Incidence of orthostatic intolerance and orthostatic hypotension after intravenous administration of morphine in patients prior to hip or knee arthroplasty.
Read the 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.
- Conditions
- Orthostatic Hypotension, Orthostatic Intolerance
- Being tested
- Morphine
- Keywords
- Orthostatic Hypotension, Orthostatic Intolerance, Morphine, Autonomic Dysfunction
- Medical subject headings
- Hypotension, Orthostatic, Orthostatic Intolerance, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Also called opioid
Administration of 0.1 mg/kg (IBW) intravenous morphine
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing primary hip or knee arthroplasty | Patients undergoing primary hip or knee arthroplasty Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of orthostatic hypotension
Orthostatic hypotension is defined as a fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg during mobilization
Measured: 30 minutes after morphine administration
Secondary outcomes (12)
Changes in systolic arterial pressure (SAP) during mobilization
Measured in mmHg by non-invasive Lithium Dilution Cardiac Output (LiDCO) measurement
Measured: Before and 30 minutes after morphine administration
Changes in diastolic arterial pressure (DAP) during mobilization
Measured in mmHg by non-invasive LiDCO
Measured: Before and 30 minutes after morphine administration
Changes in mean arterial pressure (MAP) during mobilization
Measured in mmHg by non-invasive LiDCO
Measured: Before and 30 minutes after morphine administration
Changes in heart rate (HR) during mobilization
Measured in beats min-1 by non-invasive LiDCO
Measured: Before and 30 minutes after morphine administration
Changes in stroke volume (SV) during mobilization
Measured in mL by non-invasive LiDCO
Measured: Before and 30 minutes after morphine administration
Changes in cardiac output (CO) during mobilization
Measured in L/min by non-invasive LiDCO
Measured: Before and 30 minutes after morphine administration
Changes in systemic vascular resistance (SVR) during mobilization
Measured in dynes s cm-5 by non-invasive LiDCO
Measured: Before and 30 minutes after morphine administration
Changes in peripheral perfusion index (PPI) during mobilization
Measured in % by Root Masimo
Measured: Before and 30 minutes after morphine administration
Changes in cerebral perfusion (ScO2) during mobilization
Measured in % by Root Masimo
Measured: Before and 30 minutes after morphine administration
Changes in muscular perfusion (SmO2) during mobilization
Measured in % by Root Masimo
Measured: Before and 30 minutes after morphine administration
Changes in baroreflex sensitivity - vagal (BRSv) during Valsalva manoeuvre
Measured in ms
Measured: Before and 30 minutes after morphine administration
Changes in heart rate variability (HRV) during Valsalva manoeuvre
Measured in ms
Measured: Before and 30 minutes after morphine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start1 Apr 2021
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Collaborators
- Kehlet, Henrik, M.D., Ph.D.
- Responsible party
- Principal investigator, Bodil Uldall-Hansen, Copenhagen University Hospital, Hvidovre
- Investigators
- Nicolai Bang Foss, Dr. Med., Study director, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902222
- Sponsor's protocol ID
- H-20071567
- Status last verified
- Jun 2021
- First submitted
- 20 May 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Orthostatic Intolerance and Orthostatic Hypotension After Administration of Intravenous Morphine in Patients Prior to Hip or Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04902222
- Acronym / sponsor ID
- H-20071567
- Conditions
- Orthostatic Hypotension, Orthostatic Intolerance
- Keywords
- Orthostatic Hypotension, Orthostatic Intolerance, Morphine, Autonomic Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Collaborators
- Kehlet, Henrik, M.D., Ph.D.
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing primary hip or knee arthroplasty | – | Drug: MorphinePatients undergoing primary hip or knee arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary unilateral total hip arthroplasty, total knee arthroplasty or unicompartmental knee arthroplasty
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorphineAlso: opioidAdministration of 0.1 mg/kg (IBW) intravenous morphine | Drug | Patients undergoing primary hip or knee arthroplasty |
Primary outcome
Incidence of orthostatic hypotension
Time frame: 30 minutes after morphine administration
Orthostatic hypotension is defined as a fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg during mobilization
12 secondary outcomes
Changes in systolic arterial pressure (SAP) during mobilization
Time frame: Before and 30 minutes after morphine administration
Changes in diastolic arterial pressure (DAP) during mobilization
Time frame: Before and 30 minutes after morphine administration
Changes in mean arterial pressure (MAP) during mobilization
Time frame: Before and 30 minutes after morphine administration
Changes in heart rate (HR) during mobilization
Time frame: Before and 30 minutes after morphine administration
Changes in stroke volume (SV) during mobilization
Time frame: Before and 30 minutes after morphine administration
Changes in cardiac output (CO) during mobilization
Time frame: Before and 30 minutes after morphine administration
Changes in systemic vascular resistance (SVR) during mobilization
Time frame: Before and 30 minutes after morphine administration
Changes in peripheral perfusion index (PPI) during mobilization
Time frame: Before and 30 minutes after morphine administration
Changes in cerebral perfusion (ScO2) during mobilization
Time frame: Before and 30 minutes after morphine administration
Changes in muscular perfusion (SmO2) during mobilization
Time frame: Before and 30 minutes after morphine administration
Changes in baroreflex sensitivity - vagal (BRSv) during Valsalva manoeuvre
Time frame: Before and 30 minutes after morphine administration
Changes in heart rate variability (HRV) during Valsalva manoeuvre
Time frame: Before and 30 minutes after morphine administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolai Bang Foss, Dr. Med. study director
Copenhagen University Hospital, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthostatic Hypotension and Orthostatic Intolerance, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bodil Uldall-Hansen, BA Medicine (+4528342057, bodil.uldall-hansen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of orthostatic hypotension (time frame: 30 minutes after morphine administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.