By means of resting state network measurments using fMRI we hope to gain more knowlegde about the actions (for example as an analgesic) an side effects of S(+)-ketamine on the central nervous system at different doses. Also blood samples will be…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
fMRI onderzoek in gezonde vrijwilligers
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
resting state network (fMRI)
Secondary outcome
arterial spin labeling (fMRI)
plasma concentrations of S(+)-ketamine and S(+)-norketamine
pain relief
side effects
Background summary
Many drugs influence the central nervous system, therefore is it important to
have extensive knowlegde of the pharmacological activity and the side effects.
We know that S(+)-ketamine influences the central nervou system, but we don't
know exactly were and how it works.
Study objective
By means of resting state network measurments using fMRI we hope to gain more
knowlegde about the actions (for example as an analgesic) an side effects of
S(+)-ketamine on the central nervous system at different doses. Also blood
samples will be collected to measure ketamine in the plasma, which can be
linked to the effects and side effects of ketamine.
Study design
A randomised, double blind, placebo-controlled cross-over study. There are 2
study days. On the first study day the volunteers receives intraveous
S(+)-ketamine or NaCl 0,9% during 2 hours continuously in two doses, each 1
hour. On the second study day the volunteer receives the other medication. On
preset times before, during and after the infusion fMRI scans will be made to
look at resting state network, also blood samples will be collected from the
second iv, heat pain tests will be performed and volunteers are asked to
complete questionnaires about side effects.
Intervention
Intravenous infusion of S(+)-ketamine at 20 mg/70 kg/hr for 1 hour, thereafter
40 mg/70 kg/hr for 1 hour, or an infusion with NaCl 0,9%.
Study burden and risks
The study consists of one medical examination, 1 pratice session and 2 study
days, totaling about 14 hours, for which the volunteer will be paid. Two
intravenous lines will be inserted, one of which will be used to collect blood
samples, about 100 ml per study day, hereby preventing frequent venapunctures.
Side effects of S(+)-ketamine like nausea, dizziness, dreams, diplopia, blurry
vision and a rise in blood pressure can occur. These side effects are mild and
quickly spontaneously disappear on termination of the medication. Bruising can
occur on the locations were the iv lines were inserted, they will disppear
spontaneously. Damage to the body caused by MRI can occur on the instance that
metal is present in the body (this damage will be prevented by specifically
asking the volunteers about this and by naming all examples).
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
healthy volunteers
age 18-45
right handed
naive to Ketanest-S
Exclusion criteria
Obesity (BMI > 30);
Significant history of any cardiac or vascular disorder, asthma or other pulmonary disease, major gastrointestinal abnormalities, peptic ulceration, hepatic, neurological, psychiatric, haematological (including bleeding disorders), endocrine, renal, or major genitourinary disease.
History of illness, condition or medication use that, in the opinion of the investigator, might interfere with optimal participation, confound the results of the study or pose additional risk in administering S(+)-ketamine to the subject or in making the MRIs
History of chronic alcohol or illicit drug use;
Unable to refrain from quinine containing products and grapefruit or grapefruit juice from 7 days prior to study start until the last study day.
Metal medical devices like pacemakers, knee or hip prosthesis, ear implants, vessel clips, subcutaneous insulin pumps or carries metal particles (e.g. metal splinter in the eye) inside the body.
Claustrophobia.
Allergy to study medications;
Not able to maintain a regular diurnal rhythm.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2010-021517-23-NL |
| CCMO | NL33048.058.10 |