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The NorKet Study


- candidate number3329
- NTR NumberNTR1328
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-mei-2008
- Secondary IDsP08.075  TREND, Delft (NL); BSIK03016
- Public TitleThe NorKet Study
- Scientific TitleContribution of norketamine to ketamine-induced antinociception, and cardiovascular and neurocognitive effects. A randomized, placebo-controlled, crossover study on the influence of rifampicine on ketamine-induced effects in healthy volunteers
- ACRONYMN/A
- hypothesisThis study is designed to study the contribution and quantification of norketamine for its analgetic and psychomimetic effects
- Healt Condition(s) or Problem(s) studiedPain, Ketamine , Healthy subjects, Analgesic therapy, Rifampicine
- Inclusion criteria1. Healthy male subjects.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-aug-2008
- planned closingdate1-aug-2009
- Target number of participants30
- InterventionsThe 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.
- Primary outcomeAnalgetic effect using a heat pain model
- Secondary outcomeNeurocognitive measurements(www.cnsvs.com) or;
Pharmacokinetic/pharmacodynamic analyses
- TimepointsTwo times admittance at our human laboratory for 1 day for ketamine treatment. After last visit no follow up
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. Albert Dahan
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Albert Dahan
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Anaesthesiology
- Funding
(Source(s) of Monetary or Material Support)
TREND Delft
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD27-mei-2008 - 20-jun-2008


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