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

Phase 2

Completed

Conditions: cardiovascular instability
changes in bloodpressure and heartrythm
10007521
10002861
10057166

Registration Number: NL-OMON42654

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Number of patients per dose cohort experiencing hypotension (defined as: a<br /><br>decrease in systolic, diastolic or Mean Arterial bloodpressure of >30% from<br /><br>baseline bloodpressure) for more than 5 minutes<br /><br>* Number of patients per dose cohort experiencing bradycardia (defined as: a<br /><br>heart rate below 40 beats per minute) for more than 1 minute with evidence of<br /><br>inadequate tissue perfusion (hypotension, dizziness, syncope)<br /><br>* Maximum change from baseline in heart rate<br /><br>6.1.2 </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints (if applicable)<br /><br>* Maximum change from baseline in systolic, diastolic or mean arterial<br /><br>bloodpressure in 2,5 to minute intervals<br /><br>* Time of peak plasma level of dexmedetomidine<br /><br>* Peak plasmalevel dexmedetomidine<br /><br>* Per cohort and compared to placebo and other dosage cohort:<br /><br>* Mean change in mOAA/S over time at 2,5-5 min intervals<br /><br><br /><br>Use of concomitant antihypertensive medication</p><br>