Ketamine Sedation in Mechanically Ventilated Patients

Pain Clinical Trial

Official title: Prospective Study on the Cost-Effectiveness of Adding Ketamine to Midazolam-Sufentanil Sedation Regimen in Mechanically Ventilated Patients

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Psychomotor Agitation
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

• NCT number: NCT00122759
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Didier D Dreyfuss, MD
• Phone: 33 1 47 60 61 93
• Email: didier.dreyfuss@lmr.ap-hop-paris.fr
• Status: Recruiting
• Phase: N/A
• Start date: December 2005
• Completion date: September 2007