Opioid Use, Unspecified With Other Opioid-induced Disorder
Conditions
Keywords
methylnaltrexone, opioid-antagonist, Obstipation, pharmacokinetics
Brief summary
* 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
Detailed description
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.
Interventions
DRUGMethylnaltrexone
Methylnaltrexone 12mg s.c. administered once daily until treatment stop of sufentanyl
Sponsors
University of Zurich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* hospitalisation in the neurointensive care unit * deep sedation with sufentanil doses of = 40 mcg/h * male or female aged 18 years or older * females: negative pregnancy test * Ventricular drainage as part of needed therapeutic measures
Exclusion criteria
* History of hypersensitivity to methylnaltrexone (Relistor®) * confirmed or suspected obstructive ileus or factors possibly leading to intestinal obstruction (e.g. an intestinal tumor) * increased risk for patients with localized or diffused reduction in structural integrity of the gastrointestinal tract (e.g. peptic ulcer, acute diverticulitis) * severe hepatic insufficiency (Child-Pugh Class C) * renal impairment (glomerular filtration rate \< 90 ml/min) with or without renal replacement therapy * severe diarrhea despite high opioid dosing * participation in another study with an investigational drug within the 30 days preceding and during the present study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of methylnaltrexone (Cmax, tmax, area under the curve, total clearance, halflife, accumulation ratio, renal clearance) | 5 days |
Countries
Switzerland
Outcome results
None listed