Dexmedetomidine PKPD and effect of stimulatio

Conditions: To develop a PKPD dexmedetomidine model, and to assess the effect of continuous auditory stimulation on dexmedetomidine pharmacodynamics.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2012-005443-24-NL

Lead Sponsor: MCG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To develop a PKPD dexmedetomidine model, and to assess the effect of continuous auditory stimulation on dexmedetomidine pharmacodynamics.;Secondary Objective: NA;Primary end point(s): Development of a pharmacokinetic/pharmacodynamic (PKPD) model for dexmedetomidine. For this purpose, we will gather PK-data (amount of dexmedetomidine infused at 10 second intervals, arterial dexmedetomidine plasma concentrations), and PD-data (BIS, OAA/S score), for use in model development.;Timepoint(s) of evaluation of this end point: end of study day

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The effect of stimulation on dexmedetomidine pharmacodynamics (ke0) (derived from the PKPD-model) and BIS.<br>For the pharmacodynamic part of the haemodynamic PKPD model, cardiac output, cardiac index and systemic vascular resistence will be recorded.<br>;Timepoint(s) of evaluation of this end point: end of study day