Opioid geïnduceerde ademdepressie Respiratory depression and reduced breathing
Conditions
Interventions
Intravenous administration of alfentanil by target controlled infusion (set to
achieve a concentration of 50 (first 8 subjects) and 100 (second group of 8
subjects) ng/ml).
Oral dose of Tianeptine (
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age of 18 to 35 years (inclusive);;Body Mass Index (BMI) between 18 and 35 kg/m2 (inclusive) and body weight between 50 kg and 100 kg (inclusive);;Subject is able to read and understand the written consent form, complete study*related procedures, and communicate with the study staff;;Subject is willing to comply with study restrictions
Exclusion criteria
Exclusion criteria: Clinically relevant abnormal history of physical and mental health, as determined by medical history taking and physical examinations obtained during the screening visit and/or prior to the administration of the initial dose of the study drug (as judged by the investigator); ;A semi recumbent systolic blood pressure of >160 mmHg and/or diastolic blood pressure of > 95 mmHg at screening; ;History of alcoholism or substance abuse within three years prior to screening; ;Positive pregnancy test; ;Subjects using more than 20 units of alcohol per week; Use of medication during the study period; If sexually active, the subject is not using oral contraceptives, or surgically sterilized; ;Subject has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-*prescription drugs or food; ;Participation in an investigational drug trial in the 2 months prior to administration of the initial dose of study drug or more than 5 times per year; ;Any other condition that in the opinion of the investigator would complicate or compromise the study, or the wellbeing of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the respiratory effects of an oral dose of tianeptine on alfentanil* induced respiratory depression | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the antinociceptive effects of an oral dose of tianeptine during alfentanil-infusion. | — |
Countries
Netherlands
Outcome results
None listed