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ID
Source
Brief title
Health condition
Opioid induced respiratory depression
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the respiratory effects of an oral dose of tianeptine on alfentanil-induced respiratory depression
Secondary outcome
To assess the antinociceptive effects of an oral dose of tianeptine during alfentanil infusion
Background summary
A double-blind, cross-over trial in 32 healthy volunteers to determine the influence of tianeptine (anti-depressant) on alfentanil-induced respiratory depression and analgesia
Study objective
It is hypothesized that tianeptine will prevent alfentanil‐induced
respiratory depression without affecting antinociception.
Study design
Alfentanil blood samples: baseline, 20, 50, 80, 120, 150 minutes
Vi-CO2 response baseline, after tianeptine/placebo administration, twice following start alfentanil administration (combined with tianeptine/placebo) and after stop alfentanil administration
Pain tests: (electrical and pain pressure) baseline, after tianeptine administration, twice following start alfentanil administration (combined with tianeptine/placebo) and after stop alfentanil administration
Intervention
Intravenous administration of Alfentanil by target cointrolled infusion (set to achieve a concentration of 100 ng/ml for 2 hours
Oral dose of tianeptine
a. group 1: crossover 8 subjects 37.5 mg Tianeptine/Placebo with 100 ng/ml TCI Alfentanil
b. group 2: crossover 8 subjects 50 mg Tianeptine/Placebo with 100 ng/ml TCI Alfentanil
c. group 3: crossover 8 subjects 100 mg Tianeptine/Placebo with 50 ng/ml TCI Alfentanil
d. group 4: crossover 8 subjects 100 mg Tianeptine/Placebo with 100 ng/ml TCI Alfentanil
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Inclusion criteria
Healhty volunteers (male/female)
- 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
-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 well being of the subject.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3849 |
| NTR-old | NTR4134 |
| CCMO | NL45511.058.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON40468 |