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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anders Schmidt, Lund University
ClinicalTrials.gov Identifier:
NCT01506921
First received: December 28, 2011
Last updated: February 20, 2012
Last verified: February 2012
  Purpose

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 Intervention
Healthy
Abnormal Vascular Flow
Drug: Racemic ketamine
Drug: S-ketamine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Lund University:

Primary Outcome Measures:
  • regional cerebral blood flow [ Time Frame: - Measured every 30 seconds from baseline to 45 min after study drug injection ] [ Designated as safety issue: No ]
    -In ml/100g/min


Estimated Enrollment: 14
Study Start Date: May 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506921

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

No publications provided

Responsible Party: Anders Schmidt, principal investigator, Lund University
ClinicalTrials.gov Identifier: NCT01506921     History of Changes
Other Study ID Numbers: 11 MRI-ASL
Study First Received: December 28, 2011
Last Updated: February 20, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Lund University:
racemic ketamine
S-ketamine
Cerebral blood flow
Magnetic resonance imaging
arterial spin labeling
healthy volunteers

Additional relevant MeSH terms:
Ketamine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 28, 2014