Premedication with intranasal dexmedetomidine in sedation of patients undergoing total knee arthroplasty

Phase 1

• Conditions: Knee arthrosis; MedDRA version: 21.1Level: LLTClassification code 10031165Term: Osteoarthritis kneeSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2019-003795-39-FI
• Lead Sponsor: Turku University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-10
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified