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Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning (Sevralox)

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ClinicalTrials.gov Identifier: NCT01193816
Recruitment Status : Completed
First Posted : September 2, 2010
Last Update Posted : July 18, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
This study aims to assess the efficacy of a drug (loxapine, a neuroleptic) in calming patients down in a situation of restlessness during mechanical ventilation weaning. This drug is used for several years to quieten restless patients. Its purpose is to restore spontaneous breathing sooner and therefore to reduce the risks of intubation and mechanical ventilation.

Condition or disease Intervention/treatment Phase
Restlessness Drug: loxapine Drug: Placebo Phase 4

Detailed Description:
This study aims to assess the efficacy of a drug (loxapine, a neuroleptic) in calming patients down in a situation of restlessness during mechanical ventilation weaning. This drug is used for several years to quieten restless patients. Its purpose is to restore spontaneous breathing sooner and therefore to reduce the risks of intubation and mechanical ventilation. 300 patients will participate in the study and will be randomized, after informed consent, to receive either loxapine or a placebo.Patients whose proxies refuse participation will be sedated according to standard care procedures.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning
Study Start Date : May 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: loxapine
loxapine
 Drug: loxapine
Each patient may receive a maximum dosage of 900mg of Loxapine per day (drinkable solution through gastric probe) or the same volume of placebo. 2 initial administrations of 150 mg followed by potential readministration of 100 mg of loxapine. Maximum duration of treatment will be 14 days.The dosage by day is defined by patients' clinical condition, assessed with RASS score.
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Weaning period [ Time Frame: up to 28 days ]
    Weaning period (days) between inclusion (ie first administration of loxapine/placebo) and successful extubation (no re-intubation in the following 48 hours)


Secondary Outcome Measures :
  1. total duration of mechanical ventilation [ Time Frame: up to 28 days ]
    -number of days of mechanical ventilation

  2. incidence of unexpected extubations [ Time Frame: up to 28 days ]
    number of patients with unexpected extubation

  3. clinical and biological respiratory parameters [ Time Frame: 24 hours ]
    description of abnormal clinical and biological respiratory parameters, number of patients concerned.

  4. incidence of mechanical ventilation related complications [ Time Frame: up to 48 hours after extubation ]
    collapses, nosocomial pneumonia, respiratory issue requiring an increase of FiO2 and/or PEP.

  5. incidence of adverse events, related and non related to the treatment [ Time Frame: up to 28 days ]
  6. mortality rate [ Time Frame: day 14 and week 6 ]
    mortality rate at day 14 and week 6

  7. factors associated to weaning failure [ Time Frame: up to 28 days ]
    age, patient medical history,duration of sedation or ventilation, weaning failure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥ 18 years,
  • sedated
  • under mechanical ventilation through intubation probe for more than 48 hours
  • no contra-indication to naso-gastric probe- with criteria for potential weaning
  • with social security
  • important restlessness at sedation withdrawal, defined as RASS score (Richmond Agitation Sedation Scale)= 2. This restlessness has no potential danger for the patient but requires a level of sedation. This re-sedation implies administration of morphinomimetics and benzodiazepines at dosages that does not allow to pursue mechanical ventilation weaning attempts.

Exclusion Criteria:

  • extreme restlessness at sedation withdrawal ((RASS>2)
  • allergy to loxapine or one of its component
  • dopaminergic agonists
  • extubation planned in the following 24 hours
  • antecedent of comitiality
  • known pregnancy at admission
  • proxies opposed to study participation
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01193816


Locations
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France
Hôpital Louis Mourier
Colombes, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Didier Dreyfuss, MD Assistance Publique - Hôpitaux de Paris
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01193816    
Other Study ID Numbers: P 070106
First Posted: September 2, 2010    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2012
Keywords provided by Assistance Publique - Hôpitaux de Paris:
restlessness during mechanical ventilation weaning
Additional relevant MeSH terms:
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Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Loxapine
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action