Improving Sleep After TKA Using Mirtazapine and Quetiapine
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mirtazapine, Quetiapine, Placebo.
- Who it may be relevant to
- Registry conditions: Osteo Arthritis Knee, Insomnia. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Mirtazapine and Quetiapine as Treatment for Postoperative Sleep Disturbance After Fast-track Knee Replacement
Overview
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 medication and it takes them longer to fully recover from surgery. Low doses of the tetracyclic antidepressant mirtazapine and the neuroleptic quetiapine are nowadays off-label prescribed for insomnia and improve length and quality of deep sleep phases. Quetiapine and mirtazapine could improve sleep after knee replacement surgery and improve patient recovery. This placebo-controlled, randomized, double-blind study investigates the effect of quetiapine and mirtazapine on functional recovery after total knee arthroplasty.
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.
Interventions
- Drug 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. - Drug 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. - Drug Placebo
a gelatinous capsule without an active ingredient
Primary outcome measures
- Oxford Knee Score (OKS) [Time frame: 6 weeks after surgery]
Secondary outcome measures (8)
- Leeds Sleep Evaluation questionnaire (LSEQ) [Time frame: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery]
- Visual Analogue Scale (VAS) for fatigue [Time frame: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery]
- Visual Analogue Scale (VAS) for sleep quality [Time frame: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery]
- Visual Analogue Scale (VAS) for pain in rest [Time frame: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery]
- Visual Analogue Scale (VAS) for pain during activity [Time frame: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery]
- EuroQol (EQ) 5D [Time frame: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery]
- Morphine use [Time frame: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery]
- Oxford knee score [Time frame: 1 week before surgery; first day postoperative; 2; 4; 12 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Netherlands · 2 centers
- Knowledge Center for Orthopedic Surgery, St. Anna hospital — Geldrop
- St. Anna hospital — Geldrop
Identifiers
NCT: NCT04728581 · W021-001