Methylnaltrexone Pharmacokinetics in Neurointensive Care Patients

University of Zurich9 enrolled

Overview

* 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Opioid Use, Unspecified With Other Opioid-induced Disorder

Interventions

MethylnaltrexoneDRUG

Methylnaltrexone 12mg s.c. administered once daily until treatment stop of sufentanyl

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Neurointensive Care Unit

Zurich, Switzerland

Outcomes

Primary Outcomes

Pharmacokinetic parameters of methylnaltrexone (Cmax, tmax, area under the curve, total clearance, halflife, accumulation ratio, renal clearance)

Time frame: 5 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.