Dexmedetomidine Intra Venous Arthroplasty (NCT03834129) | Clinical Trial Compass
CompletedPhase 3
Dexmedetomidine Intra Venous Arthroplasty
France94 participantsStarted 2019-05-13
Plain-language summary
Intravenous dexmedetomidine is a drug used in reanimation with sedative, anxiolytic and sympatholytic properties. Recent studies showed useful properties for anaesthesia : decrease of morphine consumption after a various type of surgery, sedative effect on patients under regional anaesthesia, prolongation of central or peripheral regional block. Dose-ranging study for intravenous dexmedetomidine showed that 2 µg/kg is an effective dose to prolong interscalene block. This study aims to determine if intravenous dexmedetomidine at 2 µg/kg allows a longer analgesic duration after a quadri-block (femoral, subgluteal sciatic, obturator and alateral cutaneous nerve blocks) with ropivacaine 0.32% for total knee replacement under regional anaesthesia.
Who can participate
Age range
18 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:
* 18 years and older
* Patients undergoing elective total knee arthroplasty
* Consent for participation
* Affiliation to the french social security system
* For women of child bearing potential without contraception, beta-HCG negative result
Exclusion Criteria:
* Chronic pain syndrome requiring preoperative morphine use (class 3)
* Hypersensitivity to dexmedetomidine
* Allergy to nonsteroidal anti-inflammatory drugs
* Contraindication for locoregional anesthesia
* Patient wishing a general anesthesia
* Weight\>100 kg, obstructive sleep apnea syndrome or gastrooesophageal reflux complicating the sedation with spontaneous ventilation
* Known acute ischemic disease
* Severe liver failure
* Uncontrolled low blood pressure
* Heart rate \< 60 bpm
* Advanced cardiac block (Level 2 or 3) except if pacemaker
* Pregnant or breastfeeding women
* Communication difficulties or neuropsychiatric disorder
* Patients under protection of the adults (guardianship, curators or safeguard of justice)
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
Evaluate the effect of dexmedetomidine infusion 2 μg/kg in pre-anesthesia and operative room, on duration of postoperative analgesia after a knee arthroplasty performed under locoregional anesthesia.