Status:
COMPLETED
Premedication with Intranasal Dexmedetomidine in Sedation of Patients Undergoing Total Knee Arthroplasty
Lead Sponsor:
Turku University Hospital
Conditions:
Knee Osteoarthritis
Pain, Postoperative
Eligibility:
All Genders
35-80 years
Phase:
PHASE4
Brief Summary
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). Anoth...
Detailed Description
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 of...
Eligibility Criteria
Inclusion
- The patient is scheduled for elective unilateral total knee arthroplasty (TKA) under spinal anesthesia
- Fluent skills in finnish language (to understand the given information and to be able to give informed consent and communicate with the study personnel)
- Age between 35 and 80 years
- Weight between 50 and 100 kg
- American Society of Anesthesiologists status 1-3
- Written informed consent from the patient
Exclusion
- A previous history of intolerance to the study drug or related compounds and additives
- Disease or condition affecting patient's ability to give written informed consent
- Existing or recent disease possible affecting absorption, distribution, metabolism, excretion or response to the study drug
- History of severe cardiac disease (valvular insufficiency, severe left ventricular dysfunction) or abnormal ECG rhythm (bradycardia \< 50/min, 2nd or 3rd degree atrioventricular-block, pacemaker)
- Preoperative systolic blood pressure \<110 mmHg
- Chronic use of strong opioids, pregabalin, gabapentin, amitriptyline or duloxetine
- Participation in any other study concomitantly or within one month prior to the entry into this study
- Clinically significant abnormal findings in physical examination or laboratory screening
- Pregnancy or breastfeeding
- Use of any drugs known to cause enzyme induction or inhibition for a period of 30 days prior to the study, use of any natural products (including grapefruit products) for at least 14 days prior to the study and caffeine containing products for at least 24 hours prior to the study. The use of regular doses of paracetamol is allowed.
Key Trial Info
Start Date :
June 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04859283
Start Date
June 10 2022
End Date
January 20 2025
Last Update
January 22 2025
Active Locations (1)
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1
Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital and University of Turku
Turku, Finland