Racemic Ketamine Versus S-ketamine With Arterial Spin Labeling (ASL)-MRI in Healthy Volunteers
A Prospective Randomised, Double-blinded Cross-over Study to Investigate the Effects of Racemic and S-ketamine on Cerebral Blood Flow on Healthy Volunteers With MRI-ASL
1 other identifier
interventional
14
1 country
1
Brief Summary
Racemic ketamine and S-ketamine are used in clinical practice today. Little is known of their difference in effect on cerebral blood flow, volume and metabolism. cerebral blood flow (CBF) measuring techniques are limited in time so constant measurement to mirror a dynamic process is impossible or very difficult. A novel MRI application, arterial spin labeling, offers the possibility that without radiation or contrast, to measure semi-continuous CBF with measurements every 60-120 seconds. The investigators will give 14 healthy volunteers both study drugs in a randomised sequence with one week apart and measure regional CBF during the study period of 45 minutes after a sub-anaesthetic bolus dose of 0,6 mg/kg racemic ketamine and 0,3 mg/kg S-ketamine The investigators hypothesize that there is no difference between racemic ketamine and S(+)-ketamine with regards to Arterial Spin Labeling (ASL) measured cerebral blood flow.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started May 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 28, 2011
CompletedFirst Posted
Study publicly available on registry
January 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFebruary 22, 2012
February 1, 2012
9 months
December 28, 2011
February 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
regional cerebral blood flow
-In ml/100g/min
- Measured every 30 seconds from baseline to 45 min after study drug injection
Study Arms (2)
Racemic ketamine
ACTIVE COMPARATORS-ketamine
ACTIVE COMPARATORAll subjects receive both study drugs in a cross- over design. Equipotent doses are used. 0,6 mg/kg racemic ketamine equals 0,3 mg/kg s-ketamine
Interventions
Eligibility Criteria
You may qualify if:
- healthy (ASA 1),
- age 18-65 years,
- fertile women must use approved anticonception during study period (2 weeks)
You may not qualify if:
- known or suspected pregnancy,
- BMI \< 30,
- motion sickness,
- claustrophobia,
- somatic or psychiatric disease,
- drug abuse,
- chronic medication,
- drug allergy,
- difficulties in understanding the written and spoken Swedish language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund Universitylead
Study Sites (1)
Deprtment of radiology, SUS, Malmö
Malmo, Malmö, 205 02, Sweden
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jonas Åkeson, profesor
Lund University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
December 28, 2011
First Posted
January 10, 2012
Study Start
May 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
February 22, 2012
Record last verified: 2012-02