Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning

NCT01193816 | Completed Phase 4

• 1 other identifier: P 070106
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 years to quieten restless patients. Its purpose is to restore spontaneous breathing sooner and therefore to reduce the risks of intubation and mechanical ventilation.

Conditions

Restlessness

Keywords

restlessness during mechanical ventilation weaning

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• total duration of mechanical ventilation

  up to 28 days

• incidence of unexpected extubations

  up to 28 days

• clinical and biological respiratory parameters

  24 hours

• incidence of mechanical ventilation related complications

  up to 48 hours after extubation

• incidence of adverse events, related and non related to the treatment

  up to 28 days

Study Arms (2)

loxapine

EXPERIMENTAL

loxapine

Drug: loxapine

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

loxapine DRUG

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.

loxapine

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Louis Mourier

Colombes, France

Location

Related Publications (1)

• Gaudry S, Sztrymf B, Sonneville R, Megarbane B, Van Der Meersch G, Vodovar D, Cohen Y, Ricard JD, Hajage D, Salomon L, Dreyfuss D. Loxapine to control agitation during weaning from mechanical ventilation. Crit Care. 2017 Sep 6;21(1):235. doi: 10.1186/s13054-017-1822-y.

  PMID: 28877705 DERIVED

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Loxapine

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dibenzoxazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Didier Dreyfuss, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: September 2, 2010
• Study Start: May 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 18, 2014

Record last verified: 2012-07

Locations

FR (1)