Ketamine Sedation in Mechanically Ventilated Patients

• ClinicalTrials.gov Identifier: NCT00122759
• Recruitment Status: Unknown
• First Posted: July 22, 2005
• Last Update Posted: July 23, 2007
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by: Assistance Publique - Hôpitaux de Paris

Tracking Information

• First Submitted Date: July 19, 2005
• First Posted Date: July 22, 2005
• Last Update Posted Date: July 23, 2007
• Study Start Date: December 2005
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: July 27, 2005)

• 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

Original Primary Outcome Measures (submitted: July 19, 2005)

• 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

Current Secondary Outcome Measures (submitted: July 19, 2005)

• Overall duration of mechanical ventilation
• Need to administer neuromuscular blocking agents

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Respiratory Insufficiency
• Pain
• Psychomotor Agitation

• Intervention: Drug: ketamine
• Study Arms: Not Provided

Publications *

• Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7.
• Ostermann ME, Keenan SP, Seiferling RA, Sibbald WJ. Sedation in the intensive care unit: a systematic review. JAMA. 2000 Mar 15;283(11):1451-9. Review.
• Bourgoin A, Albanèse J, Léone M, Sampol-Manos E, Viviand X, Martin C. Effects of sufentanil or ketamine administered in target-controlled infusion on the cerebral hemodynamics of severely brain-injured patients. Crit Care Med. 2005 May;33(5):1109-13.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 19, 2005): 100
• Original Enrollment: Same as current
• Estimated Study Completion Date: September 2007
• Primary Completion Date: Not Provided

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00122759
• Other Study ID Numbers: LMR3
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jean-Damien Ricard, MD; Assistance Publique - Hôpitaux de Paris

• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: July 2007