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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

Brief Summary:
  • 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.

Condition or disease Intervention/treatment
Respiratory Insufficiency Pain Psychomotor Agitation Drug: ketamine

Detailed Description:
  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study on the Cost-Effectiveness of Adding Ketamine to Midazolam-Sufentanil Sedation Regimen in Mechanically Ventilated Patients
Study Start Date : December 2005
Estimated Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine
U.S. FDA Resources

Primary Outcome Measures :
  1. Comparison of the adequacy of sedation in patients receiving benzodiazepine plus opiate or this combination plus adjunctive ketamine
  2. Comparison of the cost of sedation with both regimens

Secondary Outcome Measures :
  1. Overall duration of mechanical ventilation
  2. Need to administer neuromuscular blocking agents

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00122759

Contact: Didier D Dreyfuss, MD 33 1 47 60 61 93

Service de Réanimation Médicale, Hôpital Louis Mourier Recruiting
Colombes, France, 92700
Contact: Didier D Dreyfuss, MD    33 147 60 6193   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Jean-Damien Ricard, MD Assistance Publique - Hôpitaux de Paris

Publications: Identifier: NCT00122759     History of Changes
Other Study ID Numbers: LMR3
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: July 23, 2007
Last Verified: July 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Mechanical ventilation

Additional relevant MeSH terms:
Psychomotor Agitation
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
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