Ketamine Sedation in Mechanically Ventilated Patients
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|ClinicalTrials.gov 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
- 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||Phase|
|Respiratory Insufficiency Pain Psychomotor Agitation||Drug: ketamine||Not Applicable|
- 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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
- 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
- Overall duration of mechanical ventilation
- Need to administer neuromuscular blocking agents
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 ClinicalTrials.gov identifier (NCT number): NCT00122759
|Contact: Didier D Dreyfuss, MD||33 1 47 60 61 email@example.com|
|Service de Réanimation Médicale, Hôpital Louis Mourier||Recruiting|
|Colombes, France, 92700|
|Contact: Didier D Dreyfuss, MD 33 147 60 6193 firstname.lastname@example.org|
|Principal Investigator:||Jean-Damien Ricard, MD||Assistance Publique - Hôpitaux de Paris|