Ketamine Sedation in Mechanically Ventilated Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified July 2007 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00122759

First Posted: July 22, 2005

Last Update Posted: July 23, 2007

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.

Information provided by:

Assistance Publique - Hôpitaux de Paris

Tracking Information

First Submitted Date ^ICMJE

July 19, 2005

First Posted Date ^ICMJE

July 22, 2005

Last Update Posted Date

July 23, 2007

Start Date ^ICMJE

December 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ^ICMJE

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

Change History

Complete list of historical versions of study NCT00122759 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Overall duration of mechanical ventilation
Need to administer neuromuscular blocking agents

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ketamine Sedation in Mechanically Ventilated Patients

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Respiratory Insufficiency
Pain
Psychomotor Agitation

Intervention ^ICMJE

Drug: ketamine

Study Arms

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

September 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00122759

Other Study ID Numbers ^ICMJE

LMR3

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jean-Damien Ricard, MD

Assistance Publique - Hôpitaux de Paris

PRS Account

Assistance Publique - Hôpitaux de Paris

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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