Postoperative Complications Clinical Trial
Official title:
Incidence of Postoperative Orthostatic Intolerance and Postoperative Orthostatic Hypotension in Patients Undergoing Unilateral Total Knee Arthroplasty
NCT number | NCT03743116 |
Other study ID # | H-18049929 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 13, 2018 |
Est. completion date | March 1, 2020 |
Verified date | August 2022 |
Source | Hvidovre University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Incidence of Postoperative Orthostatic Intolerance and Postoperative Orthostatic Hypotension in Patients Undergoing Unilateral Total Knee Arthroplasty
Status | Completed |
Enrollment | 50 |
Est. completion date | March 1, 2020 |
Est. primary completion date | July 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Alcohol or drug abuse - Cognitive dysfunction - Known orthostatic hypotension - Use of anxiolytic drugs |
Country | Name | City | State |
---|---|---|---|
Denmark | Hvidovre University Hosptial | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital | Kehlet, Henrik, M.D., Ph.D. |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of orthostatic intolerance | Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization | 6 hours postoperatively | |
Primary | 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 | Changes in systolic arterial pressure (SAP) during mobilization | Measured in mmHg | Preoperatively, 6 and 24 hours postoperatively | |
Secondary | Changes in diastolic arterial pressure (DAP) during mobilization | Measured in mmHg | Preoperatively, 6 and 24 hours postoperatively | |
Secondary | Changes in mean arterial pressure (MAP) during mobilization | Measured in mmHg | Preoperatively, 6 and 24 hours postoperatively | |
Secondary | Changes in systemic vascular resistance (SVR) during mobilization | Measured in mmHg·min·mL-1 | Preoperatively, 6 and 24 hours postoperatively | |
Secondary | Changes in cardiac output (CO) during mobilization | Measured in mL/min | Preoperatively, 6 and 24 hours postoperatively | |
Secondary | Changes in stroke volume (SV) during mobilization | Measured in mL | Preoperatively, 6 and 24 hours postoperatively |
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