Knee osteoarthritis Hip osteoarthritis MedDRA version: 21.1 Level: LLT Classification code 10020108 Term: Hips osteoarthritis System Organ Class: 100000004859 MedDRA version: 21.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Dexdor
Product Name: Dexdor
Product Code: N05CM18
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Turku University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient is scheduled for elective unilateral total knee arthroplasty (TKA) or hip arthroplasty (THA) under general anesthesia 2. Fluent skills in finnish language (to understand the given information and to be able to give informed consent and communicate with the study personnel) 3. Age between 35 and 80 years 4. Weight between 50 and 100 kg 5. ASA (American Society of Anesthesiologists) status 1-3 6. Written informed consent from the patient Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. A previous history of intolerance to the study drug or related compounds and additives 2. Disease or condition affecting patient’s ability to give written informed consent 3. Existing or recent significant disease possible affecting absorption, distribution, metabolism, excretion or response to the study drug 4. History of cardiac disease (valvular insufficiency, severe left ventricular dysfunction) or abnormal ECG rhythm (bradycardia < 50/min, 2nd or 3rd degree AV-block, pacemaker) 5. Chronic opioid use or use of other analgesic adjuvants such as pregabalin, gabapentin, amitriptyline or duloxetine 6. Participation in any other study concomitantly or within one month prior to the entry into this study 7. Clinically significant abnormal findings in physical examination or laboratory screening 8. Use of drugs or natural products known to cause enzyme induction or inhibition 9. Pregnancy or breastfeeding 10. Spinal anesthesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We aim to measure concentration of dexmedetomidine in plasma after intranasal administration in supine, anesthetized patients. ;Secondary Objective: Adrenaline and noradrenaline plasma concentrations;Primary end point(s): Quantity of dexmedetomidine in plasma after intranasal administration;Timepoint(s) of evaluation of this end point: Venous blood samples will be obtained immediately prior to administration of dexmedetomidine (baseline) and thereafter at 5, 15, 45 min and 1, 4 h. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Adrenaline and noradrenaline plasma concentrations;Timepoint(s) of evaluation of this end point: Venous blood samples will be obtained immediately prior to administration of dexmedetomidine (baseline) and thereafter at 5, 15, 45 min and 1, 4 h. | — |
Countries
Finland
Contacts
Public ContactDivision of Perioperative Services
Turku University Hospital
Outcome results
None listed