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
  Purpose
  • 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 Intervention
Respiratory Insufficiency
Pain
Psychomotor Agitation
Drug: ketamine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Study on the Cost-Effectiveness of Adding Ketamine to Midazolam-Sufentanil Sedation Regimen in Mechanically Ventilated Patients

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Overall duration of mechanical ventilation
  • Need to administer neuromuscular blocking agents

Estimated Enrollment: 100
Study Start Date: December 2005
Estimated Study Completion Date: September 2007
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122759

Contacts
Contact: Didier D Dreyfuss, MD 33 1 47 60 61 93 didier.dreyfuss@lmr.ap-hop-paris.fr

Locations
France
Service de Réanimation Médicale, Hôpital Louis Mourier Recruiting
Colombes, France, 92700
Contact: Didier D Dreyfuss, MD    33 147 60 6193    didier.dreyfuss@lmr.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean-Damien Ricard, MD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00122759     History of Changes
Other Study ID Numbers: LMR3
Study First Received: July 19, 2005
Last Updated: July 20, 2007
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Mechanical ventilation
Agitation

Additional relevant MeSH terms:
Respiratory Insufficiency
Psychomotor Agitation
Respiration Disorders
Respiratory Tract Diseases
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Ketamine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 29, 2014