Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning
Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Restlessness
Intervention: loxapine (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s): Didier Dreyfuss, MD, Principal Investigator, Affiliation: Assistance Publique - HĂ´pitaux de Paris
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.
Clinical Details
Official title: Assessment of Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Weaning period
Secondary outcome: total duration of mechanical ventilationincidence of unexpected extubations clinical and biological respiratory parameters incidence of mechanical ventilation related complications incidence of adverse events, related and non related to the treatment mortality rate factors associated to weaning failure
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
HĂ´pital Louis Mourier, Colombes, France
Additional Information
Starting date: May 2011
Last updated: July 17, 2014
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