Ketamine Sedation in Mechanically Ventilated Patients

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: NCT00122759
Recruitment Status : Unknown
Verified July 2007 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : July 22, 2005
Last Update Posted : July 23, 2007
Information provided by:
Assistance Publique - Hôpitaux de Paris

July 19, 2005
July 22, 2005
July 23, 2007
December 2005
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  • Comparison of the adequacy of sedation in patients receiving benzodiazepine plus opiate or this combination plus adjunctive ketamine
  • Comparison of the cost of sedation with both regimens
  • Comparison of the adequacy of sedation in patients receiving benzodiazepine+opiate or this combination plus adjunction of ketamine.
  • Comparison of the cost of sedation with both regimens
Complete list of historical versions of study NCT00122759 on Archive Site
  • Overall duration of mechanical ventilation
  • Need to administer neuromuscular blocking agents
Same as current
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Ketamine Sedation in Mechanically Ventilated Patients
Prospective Study on the Cost-Effectiveness of Adding Ketamine to Midazolam-Sufentanil Sedation Regimen in Mechanically Ventilated Patients
  • Adequate sedation is of paramount importance to avoid stress and pain in mechanically ventilated patients. It is usually achieved by infusing sedatives (benzodiazepine) and analgesic (opiate) drugs.
  • This combined sedation may not be sufficient in some instances.
  • The aim of this study is to evaluate whether addition of a third substance, ketamine, allows the achievement of better sedation and avoids the use of neuromuscular blocking agents.
  • Mechanical ventilation is widely used in critically ill patients. Sedation is used in most instances to alleviate symptoms of pain and distress. It usually consists of an association of opiates and benzodiazepines.
  • In some instances, pain and agitation persist despite this combined sedation regimen. In such cases, the clinicians have the choice between increasing dosage of these 2 substances which may increase their adverse effects (mainly hypotension) and/or adding a neuromuscular blocking agent which is not devoid of adverse effects (mainly the onset of neuromyopathy of critical illness).
  • This study will assess the safety, efficacy and cost-effectiveness of adding ketamine, a well known anesthetic agent, to a combination of midazolam and sufentanil when this combination is not sufficient to reach acceptable sedation target.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Respiratory Insufficiency
  • Pain
  • Psychomotor Agitation
Drug: ketamine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
September 2007
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Inclusion Criteria:

  • Mechanically ventilated patients who receive adequate dosing of sedative agents (midazolam > 0.15 mg/kg/h plus sufentanil > 0.3 mcg/kg/h)
  • Persistence of agitation indicating that sedation is not appropriate, as assessed by validated sedation scales (Harris scare; Motor Activity Assessment scale).

Exclusion Criteria:

  • Pregnancy
  • Patient who already receives neuromuscular blocking agents
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Jean-Damien Ricard, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP