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Racemic Ketamine Versus S-ketamine With Arterial Spin Labeling (ASL)-MRI in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01506921
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : February 22, 2012
Information provided by (Responsible Party):
Anders Schmidt, Lund University

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.

Condition or disease Intervention/treatment Phase
Healthy Abnormal Vascular Flow Drug: Racemic ketamine Drug: S-ketamine Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : May 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Racemic ketamine Drug: Racemic ketamine
0.6 mg/kg
Other Name: Ketamine

Active Comparator: S-ketamine
All 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
Drug: S-ketamine
0.3 mg/kg
Other Name: Ketanest

Primary Outcome Measures :
  1. regional cerebral blood flow [ Time Frame: - Measured every 30 seconds from baseline to 45 min after study drug injection ]
    -In ml/100g/min

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01506921

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Deprtment of radiology, SUS, Malmö
Malmö, Sweden, 205 02
Sponsors and Collaborators
Lund University
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Study Director: Jonas Åkeson, profesor Lund University

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Responsible Party: Anders Schmidt, principal investigator, Lund University Identifier: NCT01506921     History of Changes
Other Study ID Numbers: 11 MRI-ASL
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012
Keywords provided by Anders Schmidt, Lund University:
racemic ketamine
Cerebral blood flow
Magnetic resonance imaging
arterial spin labeling
healthy volunteers
Additional relevant MeSH terms:
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Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents
Psychotropic Drugs