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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-008597-31-SE
Enrollment
Unknown
Registered
2009-04-20
Start date
2010-08-17
Completion date
Unknown
Last updated
2012-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Ketanest Product Name: Ketanest Pharmaceutical Form: Injection* Trade Name: Ketalar Product Name: Ketalar Pharmaceutical Form: Injection*

Sponsors

Malmoe University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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. Secondary endpoints; to validate differences in effects of the two substances on cerebral metabolism with spectroscopy-MRI.—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026