Is dexmedetomidine a safe medicine to calm elderly patients when they are waiting for an operation?
- Conditions
- Anxiety, preoperativeTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2015-004587-11-NL
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48
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 subject 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the safety and tolerability of single ascending intranasal bolus doses of dexmedetomidine in people aged over 65;Secondary Objective: To assess the pharmacokinetic and pharmocodynamic profile of dexmedetomidine after intranasal administration in elderly subject.;Primary end point(s): •Number of subjects per dose cohort experiencing hypotension (defined as: a decrease in systolic, diastolic or Mean Arterial bloodpressure of >30% from baseline bloodpressure) for more than 5 minutes<br>•Number of subjects per dose cohort experiencing bradycardia (defined as: a heart rate below 40 beats per minute) for more than 1 minute with evidence of inadequate tissue perfusion (hypotension, dizziness, syncope)<br>•Maximum change from baseline in heart rate<br>;Timepoint(s) of evaluation of this end point: After inclusion of all subjects or when the safety stopping criteria have been met
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Maximum change from baseline in systolic, diastolic or mean arterial bloodpressure in 2,5 to minute intervals<br>•Time of peak plasma level of dexmedetomidine<br>•Peak plasmalevel dexmedetomidine <br>•Per cohort and compared to placebo and other dosage cohort:<br>•Mean change in mOAA/S over time at 2,5-5 min intervals<br>;Timepoint(s) of evaluation of this end point: After inclusion of all subjects or when the safety stopping criteria have been met