Opioid Use, Unspecified With Other Opioid-induced Disorder Clinical Trial
Official title:
Pharmacokinetics of Once Daily Subcutaneous Methylnaltrexone in Neurointensive Care Patients With High Dose Sufentanil Analgosedation
- Assessment of pharmacokinetic parameters of once daily subcutaneously administered
methylnaltrexone in 10 evaluable neurointensive care patients.
- Quantification of methylnaltrexone passage through the blood-brain-barrier in
critically ill patients with severe cerebral affections.
- Observation of laxation response after methylnaltrexone application and relation to
plasma concentrations of methylnaltrexone.
- Assessing the safety of once daily administered methylnaltrexone in neurointensive care
patients.
- Trial with medicinal product
After administration of methylnaltrexone s.c. multiple peripheral blood samples and additionally two liquor samples are drawn during a dose interval on day 1, 3, and 5 of drug administration. ;
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment