Premedication with Intranasal Dexmedetomidine in Sedation of Patients Undergoing Total Knee Arthr… (NCT04859283) | Clinical Trial Compass
CompletedPhase 4
Premedication with Intranasal Dexmedetomidine in Sedation of Patients Undergoing Total Knee Arthroplasty
Finland100 participantsStarted 2022-06-10
Plain-language 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). Another aim is to determine if premedication with intranasal dexmedetomidine could provide sufficient sedation to alleviate anxiety during TKA.
Who can participate
Age range
35 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in numerical rating scale (NRS 0-100 mm, min 0, max 100, higher score means worse outcome)
Timeframe: 24 hours
2
Change in intraoperative sedatives (mg) administered
Timeframe: From anesthesia induction to the end of surgery.
. 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