No registrations found.
ID
Source
Brief title
Health condition
Pharmacology
Pain
Healthy volunteers
Sponsors and support
Intervention
Outcome measures
Primary outcome
Analgetic effect using a heat pain model
Secondary outcome
Neurocognitive measurements(www.cnsvs.com) or;
Pharmacokinetic/pharmacodynamic analyses
Background summary
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.
Study objective
This study is designed to study the contribution and quantification of norketamine for its analgetic and psychomimetic effects
Study design
Two times admittance at our human laboratory for 1 day for ketamine treatment. After last visit no follow up
Intervention
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.
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
1. Healthy male subjects.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1282 |
| NTR-old | NTR1328 |
| Other | TREND, Delft (NL); BSIK03016 : P08.075 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |