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NCT Number: NCT04728581

Improving Sleep After TKA Using Mirtazapine and Quetiapine

Use of mirtazapine and quetiapine for improvement of sleep quality after TKA

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Key information

Conditions

Osteo Arthritis Knee Dyssomnias Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Knowledge Center for Orthopedic Surgery, St. Anna hospital, Geldrop, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mirtazapine

Drug

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

Drug

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

Drug

a gelatinous capsule without an active ingredient

Primary outcomes

  1. Oxford Knee Score (OKS)

    Time frame: 6 weeks after surgery

    Validated functional knee score after TKA, minimum score 12 (best outcome), maximum score 60 (worst outcome)

Secondary outcomes

  1. Leeds Sleep Evaluation questionnaire (LSEQ)

    Time frame: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery

    Validated sleep score in 3 dimensions of sleep

  2. Visual Analogue Scale (VAS) for fatigue

    Time frame: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery

    Visual analogue reporting of fatigue after sleep, indicated on a 0 (best outcome) to 100 (worst outcome) mm line

  3. 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 reporting of quality sleep, indicated on a 0 (worst outcome) to 100 (best outcome) mm line

  4. 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 reporting of knee pain while resting, indicated on a 0 (best outcome) to 100 (worst outcome) mm line

  5. Visual Analogue Scale (VAS) for pain during activity

    Time frame: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery

    Visual analogue reporting of knee pain during exercises, indicated on a 0 (best outcome) to 100 (worst outcome) mm line

  6. EuroQol (EQ) 5D

    Time frame: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery

    General well being score, full health represented by 11111 score (overall score for the Netherlands of 1,000), worst health represented by 55555 score (overal score for the Netherlands of -0,329)

  7. Morphine use

    Time frame: 1 week before surgery; first day postoperative; 2; 4; 6; 12 weeks after surgery

    Total amount (mg) morphine use after surgery is documented

  8. Oxford knee score

    Time frame: 1 week before surgery; first day postoperative; 2; 4; 12 weeks after surgery

    Validated functional knee score after TKA, minimum score 12 (best outcome), maximum score 60 (worst outcome)

Study contacts

Contact information is provided by the study sponsor or research team.

Michiel Siebelt

CONTACT

Walter van der Weegen

CONTACT

[email protected]

06-34282788

Sponsors and collaborators

Lead sponsor

St. Anna Ziekenhuis, Geldrop, Netherlands

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 28, 2021
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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