Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pharmacokinetics of Once Daily Subcutaneous Methylnaltrexone in Neurointensive Care Patients With High Dose Sufentanil Analgosedation

Conditions
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Opioid Use, Unspecified With Other Opioid-induced Disorder

Intervention / Treatment
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* Drug: Methylnaltrexone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylnaltrexone<br>Pharmacokinetics of methylnaltrexone administered once daily | Drug: Methylnaltrexone<br>* Methylnaltrexone 12mg s.c. administered once daily until treatment stop of sufentanyl<br>* Other names: Relistor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters of methylnaltrexone (Cmax, tmax, area under the curve, total clearance, halflife, accumulation ratio, renal clearance) |  | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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methylnaltrexone, opioid-antagonist, Obstipation, pharmacokinetics