Status:
COMPLETED
Dexmedetomidine Intra Venous Arthroplasty
Lead Sponsor:
CMC Ambroise Paré
Conditions:
Primary Total Knee Arthroplasty
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 consump...
Detailed Description
This is a prospective, randomized, double-blind controlled trial with two parallel groups. All patients undergoing total knee arthroplasty under regional anaesthesia and sedation will be screened for ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2020
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT03834129
Start Date
May 13 2019
End Date
January 11 2020
Last Update
February 7 2020
Active Locations (1)
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1
Clinique Médipôle Garonne
Toulouse, Haute-Garonne, France, 31036