Racemic Ketamine Versus S-ketamine With Arterial Spin Labeling (ASL)-MRI in Healthy Volunteers (NCT01506921) | Clinical Trial Compass
CompletedNot Applicable
Racemic Ketamine Versus S-ketamine With Arterial Spin Labeling (ASL)-MRI in Healthy Volunteers
Sweden14 participantsStarted 2011-05
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* healthy (ASA 1),
* age 18-65 years,
* fertile women must use approved anticonception during study period (2 weeks)
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
regional cerebral blood flow
Timeframe: - Measured every 30 seconds from baseline to 45 min after study drug injection