Safety, tolerability and sedative properties of single dose intranasal dexmedetomidine premedication in elderly subjects. - KUKIDEX-1

niversitair Medisch Centrum Groningen0 个研究点目标入组 48 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•1. Planned for a maxillofacial procedure under general anesthetic in the UMCG planned on one of the planned study days
•2. Completed and cleared through the pre-anesthetic screening as per the standard protocol
•3. Adult, men and women, over 65 years of age, inclusive.
•4. Body Mass Index (BMI) * 17.5 and * 30.5 kg/m2, inclusive, and a total body weight >50 kg, at screening and check-in.
•5. American Society of Anesthesiologists (ASA) Physical Status 1 or 2 as determined in the preprocedural anaesthesiological screening
•6. Obtain a score of I or II using the Modified Mallampati Scoring.
•7. Understand the study procedures in the informed consent form(s) (ICF(s)), and be willing and able to comply with the protocol.
•8. For inclusion in the beta blocked arm subjects only: taking beta blocking medication at home in any dose or prescription.

•1. For inclusion into the non-beta blocked arm: taking any type of beta-receptor blocking medication
•2. Contraindications for the use of dexmedetomidine
•3. Known intolerance to dexmedetomidine
•4. History or presence of significant cardiovascular disease (ASA >2), or significant cardiovascular disease risk factors, significant coronary artery disease, or any known genetic pre disposition to cardiac arrhythmia (including long QT syndrome.)
•5. History or presence of significant (ASA >2) pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological (inclusive of any seizure disorder), or psychiatric disease.
•6. History of any illness or medication use that, in the opinion of the PI, might confound the results of the study or pose an additional risk to the patient by their participation in the study.
•7. Surgery within the past 90 days prior to dosing judged by the PI to be clinically relevant.
•8. History of febrile illness within 5 days prior to dosing.
•9. History or presence of alcoholism or drug abuse within the past 2 years.
•10. Hypersensitivity or idiosyncratic reaction to components of dexmedetomidine, placebo components, or to compounds related to the study medications.
•11. Single 12-lead ECG demonstrating QTcF interval >450 msec at screening ;12. Patient refusal

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