A Phase 4 interventional study of Dexmedetomidine and Placebo in Knee Osteoarthritis and Pain, Postoperative, sponsored by Turku University Hospital. Completed at 1 site in Finland. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-22.
Sponsored by Turku University Hospital · Phase 4, Interventional, and Treatment
This study aims to find out if preoperatively given dexmedetomidine is effective analgesic adjuvant for treating postoperative pain in patients undergoing elective total knee arthroplasty (TKA). Another aim is to determine if premedication with intranasal dexmedetomidine could provide sufficient sedation to alleviate anxiety during TKA.
Patients undergoing total knee arthroplasty (TKA) under spinal anesthesia often request sedation to alleviate anxiety. Dexmedetomidine may be ideally suited to provide sedation during surgery as it offers sedation and analgesia without causing significant respiratory depression. Furthermore, dexmedetomidine has beneficial synergistic interactions with opioids and sedative drugs.
Altogether 80 patients scheduled for elective unilateral TKA under spinal anesthesia will be included in the prospective, randomized and controlled parallel-group study. Patients will be randomized into two groups, forty patients in each group. All patients will receive preoperatively 1000 mg of oral paracetamol as premedication. One group receives a single bolus dose of intranasal 1 ug/kg dexmedetomidine (DEX group) and the other group receives euvolemic dose (10 µL/kg) of saline (PLACEBO-group).
Spinal anesthesia will be performed using bupivacaine (5 mg/mL) using 2.0-2.5 mL dose, the amount depending on the clinical judgement of the anesthesiologist responsible for the patient. If patient needs additional analgesic after spinal anesthesia, 50 µg dose of intravenous fentanyl or 3-5 mg of intravenous midazolam may be administered intraoperatively.
Postoperative pain management in the surgical ward includes oral paracetamol 1000 mg every 8 hours, and from the first postoperative day onwards patients receive oral naproxen/esomeprazole 500/20 mg twice a day. Oral oxycodone (5-10 mg) will be used, if the pain (measured with numerical rating scale, NRS, min 0, max 100, higher scores mean worse outcome) is moderate or intense (NRS>30) after paracetamol and naproxen.
Postoperative pain (NRS) and opioid consumption (mg) will be measured and analysed together with intraoperative sedative used (mg, midazolam and/or fentanyl allowed).
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's enrollment of 100 is above the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Turku University Hospital is the lead sponsor of 286 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
intranasal dexmedetomidine 1 µg/kg
Drug: Dexmedetomidine
intranasal saline 10 µL/kg
Drug: Placebo
Intranasal dexmedetomidine 1µg/kg will be administered 30min before the induction of anesthesia using a LMA MAD Nasal-device
Also known as: Dexdor
Intranasal saline (10 µL/kg) will be administered 30 min before the induction of anesthesia using a LMA MAD NasalTM -device. The dose is euvolemic to 1 µg/mL dexmedetomidine.
Also known as: Saline
Change in numerical rating scale (NRS 0-100 mm, min 0, max 100, higher score means worse outcome)
Number of patients with visual rating scale value under 30 mm
Time frame: 24 hours
Change in intraoperative sedatives (mg) administered
Change from baseline midazolam and fentanyl consumption (mg)
Time frame: From anesthesia induction to the end of surgery.
Change in opioid consumption (mg) postoperatively
Change from baseline opioid consumption (mg) postoperatively at 24 hours
Time frame: 24 hours
Change (mmHg) in hemodynamic parameter (blood pressure)
More than 30% change from the baseline in the blood pressure (measured in mmHg)
Time frame: 24 hours
Change (%) in respiratory parameter (peripheral oxygen saturation, SpO2)
More than 10% change from the baseline in the SpO2 (measured %)
Time frame: 24 hours
Number of patients with adverse events as a measure of safety and tolerability
Number of patients with adverse events as a measure of safety and tolerability
Time frame: 24 hours
Plan to share: No
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine