Status:
NOT_YET_RECRUITING
Improving Sleep After TKA Using Mirtazapine and Quetiapine
Lead Sponsor:
St. Anna Ziekenhuis, Geldrop, Netherlands
Conditions:
Osteo Arthritis Knee
Insomnia
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Use of mirtazapine and quetiapine for improvement of sleep quality after TKA
Detailed Description
Background After knee replacement surgery there is a loss of quantity and quality of sleep. Loss of sleep is associated with increased pain perception. Subsequently, patients use more analgesic medica...
Eligibility Criteria
Inclusion
- Indication for TKA
Exclusion
- use of benzodiazepines
- use of anti-depressants
- use of oxycodone
- patients diagnosed with obstructive sleep apnea syndrome, severe respiratory insufficiency, or myasthenia
- a known hypersensitivity to mirtazapine, quetiapine and/or related to the gelatinous (placebo) capsule
- insufficient understanding of the Dutch language.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT04728581
Start Date
January 1 2024
End Date
January 1 2027
Last Update
June 2 2023
Active Locations (2)
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1
Knowledge Center for Orthopedic Surgery, St. Anna hospital
Geldrop, Netherlands
2
St. Anna hospital
Geldrop, Netherlands