Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning

Restlessness Clinical Trial

— Sevralox  

Official title:

Assessment of Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01193816
• Other study ID #: P 070106
• Status: Completed
• Phase: Phase 4
• First received: August 26, 2010
• Last updated: July 17, 2014
• Start date: May 2011
• Est. completion date: July 2014

Study information

• Verified date: July 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restlessness

Intervention

Drug:
• loxapine
Each 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.
• Placebo
Placebo

Locations

Country	Name	City	State
France	Hôpital Louis Mourier	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weaning period	Weaning period (days) between inclusion (ie first administration of loxapine/placebo) and successful extubation (no re-intubation in the following 48 hours)	up to 28 days	No
Secondary	total duration of mechanical ventilation	-number of days of mechanical ventilation	up to 28 days	No
Secondary	incidence of unexpected extubations	number of patients with unexpected extubation	up to 28 days	No
Secondary	clinical and biological respiratory parameters	description of abnormal clinical and biological respiratory parameters, number of patients concerned.	24 hours	Yes
Secondary	incidence of mechanical ventilation related complications	collapses, nosocomial pneumonia, respiratory issue requiring an increase of FiO2 and/or PEP.	up to 48 hours after extubation	No
Secondary	incidence of adverse events, related and non related to the treatment		up to 28 days	Yes
Secondary	mortality rate	mortality rate at day 14 and week 6	day 14 and week 6	No
Secondary	factors associated to weaning failure	age, patient medical history,duration of sedation or ventilation, weaning failure	up to 28 days	No