Safety, tolerability and sedative properties of intranasal dexmedetomidine premedication in elderly people
- Conditions
- pharmacodynamicspharmacokineticshemodynamic changes
- Registration Number
- NL-OMON27385
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- 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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Number of patients per dose cohort experiencing hypotension (signs of hypoperfusion, systolic, diastolic or mean arterial bloodpressure >30% below baseline) for more than 5 minutes<br /><br>•Number of patients 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 /><br>•Maximum change from baseline in heart rate<br>
- Secondary Outcome Measures
Name Time Method •Maximum change from baseline in systolic, diastolic or mean arterial 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>