It is hypothesized that tianeptine will prevent alfentanil‐induced respiratory depression without affecting antinociception.
ID
Bron
Verkorte titel
Aandoening
Opioid induced respiratory depression
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To assess the respiratory effects of an oral dose of tianeptine on alfentanil-induced respiratory depression
Achtergrond van het onderzoek
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
Doel van het onderzoek
It is hypothesized that tianeptine will prevent alfentanil‐induced
respiratory depression without affecting antinociception.
Onderzoeksopzet
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
Onderzoeksproduct en/of interventie
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
Publiek
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Wetenschappelijk
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL3849 |
NTR-old | NTR4134 |
CCMO | NL45511.058.13 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON40468 |