Dexmedetomidine Intra Venous Arthroplasty

• Status: Completed
• Trial end date: 2020-01-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CMC Ambroise Paré
• Treatments: Dexmedetomidine

Criteria

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)