Restlessness | Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning
Restlessness research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:loxapineEach 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: May 2011
Completed Date: July 2014
Phase: Phase 4
Primary Outcome: Weaning period
Secondary Outcome: total duration of mechanical ventilation
Study sponsors, principal investigator, and references
Principal Investigator: Didier Dreyfuss, MD
Lead Sponsor: Assistance Publique - Hôpitaux de Paris