This study is designed to study the contribution and quantification of norketamine for its analgetic and psychomimetic effects
ID
Bron
Verkorte titel
Aandoening
Pharmacology
Pain
Healthy volunteers
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Analgetic effect using a heat pain model
Achtergrond van het onderzoek
The analgesic effects of S(+)-ketamine are known. S(+)-ketamine effects neurocognition. The contribution of its metabolite is however not known. With this study we are inducing the metabolism of S(+)-ketamine into norketamine. Heat pain is induced in healthy male volunteers, and VAS pain score will be obtained at the same time as blood samples are taken for pk/pd analysis. Also neurocognition is tested.
Doel van het onderzoek
This study is designed to study the contribution and quantification of norketamine for its analgetic and psychomimetic effects
Onderzoeksopzet
Two times admittance at our human laboratory for 1 day for ketamine treatment. After last visit no follow up
Onderzoeksproduct en/of interventie
The NorKet study consists of 2 studies: study A and study B. 15 volunteers will take part in study A. They will be admitted twice, with at least 3 weeks in between, at our human laboratory for 1 day during which measurements will take place. 5 days before each measurement day the volunteers will receive pretreatment with placebo on one occasion and rifampicine on the other occasion. During measurement day volunteers will be infused with S(+)-ketamine for 2 hours (the amount is based on weight, the infusion rate is 20 mg/h for a 70 kg subject). During and after infusion with S(+)-ketamine heat pain will be induced at several time points, the amount of pain is scored by VAS. Also arterial blood samples are taken for pk/pd analysis. 15 volunteers will take part in study B. They will be admitted 3 times, with at least 3 weeks in between, at our human laboratory for 1 day during which measurements will take place. 5 days before each measurement day the volunteers will receive pretreatment with placebo on 1 or 2 occasions and rifampicine on 1 or 2 other occasions. During measurement day volunteers will be infused with placebo (first occasion) or S(+)-ketamine (second and third occasion) for 2 hours (the amount is based on weight, the infusion rate is 20 mg/h for a 70 kg subject). During and after infusion with placebo or S(+)-ketamine heat pain will be induced at several time points, the amount of pain is scored by VAS. Also neurocognitive tests will be performed.
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)
1. Healthy male subjects.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Obesity (BMI > 30);
2. Presence of medical disease (heart-, lung-, liver-,
kidney-, neurologic disease; diabetes m.; pyrosis;
diaphragmatic hernia);
3. Presence of psychiatric disease;
4. History of chronic alcohol or illicit drug use;
5. Allergy to study medications;
6. Color blindness;
7.
Use of contact lenses.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1282 |
| NTR-old | NTR1328 |
| Ander register | TREND, Delft (NL); BSIK03016 : P08.075 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |