Improving Sleep After TKA Using Mirtazapine and Quetiapine
NCT ID: NCT04728581
Last Updated: 2023-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
165 participants
INTERVENTIONAL
2024-01-01
2027-01-01
Brief Summary
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Detailed Description
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Methods This is a prospective, single center, double-blinded randomized controlled trial. 165 patients with knee osteoarthritis scheduled for total knee arthroplasty will be randomly allocated to a low-dose quetiapine (LDQ), a low-dose mirtazapine (LDM) group or a placebo group. Outcomes will be evaluated at baseline, 2, 4, 6 and 12 weeks after surgery. Functional outcome after total knee arthroplasty is measured using a patient related outcome measure through the Oxford Knee Score (OKS). In order to measure postoperative sleep quality, patients will be monitored using the Leeds Sleep evaluation questionnaire (LSEQ). Furthermore, pain is registered using a visual analogue scale (VAS), weekly opioid use is monitored, and general health status is reported through the EQ-5D. Analyses will be conducted on an intention-to-treat basis using logistic and linear mixed regression models. This trial complies with the SPIRIT guidelines for randomized controlled trials.
Discussion This study will provide clinicians with evidence whether quetiapine contributes to rehabilitation of patients undergoing fast-track knee replacement surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
use of placebo during first 2 weeks after TKA surgery
Placebo
a gelatinous capsule without an active ingredient
Low dose Mirtazapine
Use of Mirtazapine 3.75mg before lights-out, allowed to increase medication to 7.5mg
Mirtazapine
Use of 3.75mg mirtazapine before lights-out during first 2 weeks after TKA surgery. With insufficient effect on sleep, patients are allowed to increase medication to 7.5mg mirtazapine.
Low dose Quetiapine
use of Quetiapine 3.125mg before lights-out, allowed to increase medication to 6.25mg
Quetiapine
Use of 3.125mg quetiapine before lights-out during first 2 weeks after TKA surgery. With insufficient effect on sleep, patients are allowed to increase medication to 6.25mg mirtazapine.
Interventions
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Mirtazapine
Use of 3.75mg mirtazapine before lights-out during first 2 weeks after TKA surgery. With insufficient effect on sleep, patients are allowed to increase medication to 7.5mg mirtazapine.
Quetiapine
Use of 3.125mg quetiapine before lights-out during first 2 weeks after TKA surgery. With insufficient effect on sleep, patients are allowed to increase medication to 6.25mg mirtazapine.
Placebo
a gelatinous capsule without an active ingredient
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
50 Years
ALL
Yes
Sponsors
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St. Anna Ziekenhuis, Geldrop, Netherlands
OTHER
Responsible Party
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Walter van der Weegen
PhD
Locations
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Knowledge Center for Orthopedic Surgery, St. Anna hospital
Geldrop, , Netherlands
St. Anna hospital
Geldrop, , Netherlands
Countries
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Central Contacts
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Michiel Siebelt
Role: CONTACT
Facility Contacts
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Other Identifiers
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W021-001
Identifier Type: -
Identifier Source: org_study_id
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