drugset / Trial / NCT01193816

Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning

NCT01193816 ↗

Phase 4 Completed 100 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2011-05
Primary completion
2014-05
Completion
2014-07

Outcome

Missed primary endpoint

paper Median times to successful extubation were 3.2 days in the loxapine group and 5 days in the placebo group (relative risk 1.2, 95% CI 0.75-1.88, p = 0.45). PMID 28877705 ↗

paper In this prematurely stopped trial, loxapine did not significantly shorten weaning from MV. PMID 28877705 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject loxapine Small molecule 100 mg Other

Indications

No indication recorded.