Knee arthrosis MedDRA version: 21.1 Level: LLT Classification code 10031165 Term: Osteoarthritis knee System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Dexdor
Product Name: Dexdor
Product Code: N05CM18
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical form of the placebo: Infusion
Route of administration of the pla
Sponsors
Turku University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient is scheduled for elective unilateral total knee arthroplasty (TKA) under spinal 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
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. A previous intolerance to non-steroidal anti-inflammatory drugs (NSAIDs) 11. Preoperative systolic blood pressure <110mmHg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study aims to determine if premedication with intranasal dexmedetomidine could provide sufficient sedation to alleviate anxiety during total knee arthroplasty surgery.;Secondary Objective: We also want to find out if preoperatively given dexmedetomidine is effective analgesic adjuvant for treating postoperative pain in patients undergoing elective knee arthroplasty.;Primary end point(s): 1. Postoperative pain measured with visual analogue score 2. Amount of additional intraoperative sedatives needed 3. Postoperative opioid consumption;Timepoint(s) of evaluation of this end point: 1. Postoperative pain is recorded at the post-anesthesia care unit and at the ward regularly 2. Evaluation is performed when patient is transferred from operating room to post-anesthesia care unit 3. Cumulative opioid consumption is recorded from transfer to PACU to hospital discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Perioperative hemodynamics 2. Perioperative respiration 3. Patient satisfaction;Timepoint(s) of evaluation of this end point: 1. Hemodynamic parameters recorded in the perioperative period 2. Respiratory parameters recorded in the preoperative period 3. Patient satisfaction will be assessed with a phone call 30 days after the procedure | — |
Countries
Finland
Contacts
Public ContactDivision of Perioperative Services
Turku University Hospital
Outcome results
None listed