Pharmacokinetics and pharmacodynamics of esketamine during longterm sedation of children at the intensive care
Completed
- Conditions
- Sedatie bij intubatie tbv beademingsedation
- Registration Number
- NL-OMON35741
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Sedation with ketamine and lorazepam with protocol: Sedation and analgesia during artificial respiration > 1 week
2. Presence of an arterial or central line for blood sampling
3. Presence of an Informed Consent
Exclusion Criteria
1. A contra indication for the use of ketamine:
** Increased intracranial pressure leading to serious risks.
** Hypersensitivity for the farmacon
2. Absence of Informed Consent
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. The PK parameters of esketamine; clearance, distributionvolume and half life.<br /><br><br /><br>2.The PD parameters of esketamine; EC50 (concentration at half Emax) and Emax<br /><br>(maximal effect). These parameters characterize the relationship between<br /><br>plasmaconcentration of esketamine and the sedative effect (COMFORT-B score). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Inter- and intra-patient variability of the PK and PD parameters of esketamine. </p><br>