Intranasal dexmedetomidine pharmacokinetics on patients under general anesthesia

Phase 1

• Conditions: Knee osteoarthritisHip osteoarthritis; MedDRA version: 21.1Level: LLTClassification code 10020108Term: Hips osteoarthritisSystem Organ Class: 100000004859; MedDRA version: 21.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2020-004931-25-FI
• Lead Sponsor: Turku University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-17
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

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