Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Loxapine

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