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Clinical trial

Mirtazapine and Quetiapine as Treatment for Postoperative Sleep Disturbance After Fast-track Knee Replacement

ID
Name
W021-001
Description
Use of mirtazapine and quetiapine for improvement of sleep quality after TKA
Trial arms
Trial start
2024-01-01
Estimated PCD
2026-05-01
Trial end
2027-01-01
Status
Not yet recruiting
Treatment
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.
Arms:
Low dose 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.
Arms:
Low dose Quetiapine
Placebo
a gelatinous capsule without an active ingredient
Arms:
Placebo
Size
165
Primary endpoint
Oxford Knee Score (OKS)
6 weeks after surgery
Eligibility criteria
Inclusion Criteria: * Indication for TKA Exclusion Criteria: * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Placebo controlled trial', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 165, 'type': 'ESTIMATED'}}
Updated at
2023-06-02

1 organization

2 products

1 drug

2 indications

Organization
St. Anna Ziekenhuis
Product
Mirtazapine
Indication
Osteoarthritis of the Knee
Indication
Insomnia
Product
Quetiapine
Drug
Varlilumab