Development of a pharmacokinetic/pharmacodynamic model of dexmedetomidine, and the effect of repeated auditory stimulation on pharmacodynamics of dexmedetomidine.*

Completed

• Conditions: gezonde vrijwilligers, dus geen aandoeningen; pharmacodynamic; Pharmacokinetic

• Registration Number: NL-OMON39625
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

American Society of Anesthesiologists (ASA) Physical Status 1
No medical history of significance
No chronic use of medication, alcohol, drugs or tobacco (oral contraceptives excluded).

Exclusion Criteria

Contraindications for use of dexmedetomidine
Known intolerance to dexmedetomidine
Body mass index (BMI) <18 or >35 kg/m2
Volunteer refusal
Pregnancy, or currently nursing

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To develop a pharmacokinetic/pharmacodynamic (PKPD) model for dexmedetomidine,<br /><br>for use in plasma concentration targeted and effect site targeted TC</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the effect of stimulation on dexmedetomidine pharmacodynamics and<br /><br>EEG-monitoring.<br /><br>To develop a PKPD model based on haemodynamic side effects (changes in cardiac<br /><br>output).</p><br>