Comparative study to evaluate the effects of racemic ketamin versus s-ketamine on cerebral blood flow, blood volume and metabolism - S-ketaminv1,2008-12-16

Conditions: Racemic ketamine is used for sedation, analgesia and anesthesia to patients in various forms of circulatory compromise ie shock. The enantiomere S-ketamine has not been compared regarding cerebral effects, ie CBF, CBV and metabolism with its mothercompound, might prove beneficial regarding these effect parameters, and should be used instead.

Registration Number: EUCTR2008-008597-31-SE

Lead Sponsor: Malmoe University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Healthy
2. American society of anesthesiologists (ASA) risc group 1
3. Age 18-65
4. Informed consent
5. Fertile females must use anticonception during studyperiod (2 weeks)

i.e. volunteering healthy medical students in a non-dependent situation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known or suspected pregnancy or lactation.
2. Obesitas (BMI >30).
3. Motion sickness.
4. Claustrofobia.
5. Current or earlier somatic or psychiatric disease.
6. Drug use or abuse.
7. Chronic medication.
8. Known or suspected allergy to medications or substances used in the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effects of racemic ketamine and the enantiomere S(+) -ketamine on cerebral blood flow, blood volume and metabolism on healthy volunteers.;Secondary Objective: To evaluate the Arterial Spin Labelling (ASL) MRI application on almost continuous variables (CBV, CBF) and to compare it with perfusion- MRI;Primary end point(s): Primary endpoints; to validate differences in effects of the two substances on cerebral blood flow and cerebral blood volume with arterial spin labelling MRI (ASL-MRI) and perfusion-MRI. <br><br>Secondary endpoints; to validate differences in effects of the two substances on cerebral metabolism with spectroscopy-MRI.

Secondary Outcome Measures