Ketamine Sedation in Mechanically Ventilated Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00122759
First received: July 19, 2005
Last updated: July 20, 2007
Last verified: July 2007

July 19, 2005
July 20, 2007
December 2005
Not Provided
  • 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 regimen
Complete list of historical versions of study NCT00122759 on ClinicalTrials.gov Archive Site
  • Overall duration of mechanical ventilation
  • Need to administer neuromuscular blocking agents
Same as current
Not Provided
Not Provided
 
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Respiratory Insufficiency
  • Pain
  • Psychomotor Agitation
Drug: ketamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
September 2007
Not Provided

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
Both
18 Years and older
No
Contact: Didier D Dreyfuss, MD 33 1 47 60 61 93 didier.dreyfuss@lmr.ap-hop-paris.fr
France
 
NCT00122759
LMR3
No
Not Provided
Assistance Publique - Hôpitaux de Paris
Not Provided
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