Status:
COMPLETED
Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Restlessness
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01193816
Start Date
May 1 2011
End Date
July 1 2014
Last Update
July 18 2014
Active Locations (1)
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1
Hôpital Louis Mourier
Colombes, France