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NCT Number: NCT01193816

Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital Louis Mourier

Colombes, France

About 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo

Drug

Placebo

Primary outcomes

  1. Weaning period

    Time frame: up to 28 days

    Weaning period (days) between inclusion (ie first administration of loxapine/placebo) and successful extubation (no re-intubation in the following 48 hours)

Secondary outcomes

  1. total duration of mechanical ventilation

    Time frame: up to 28 days

    -number of days of mechanical ventilation

  2. incidence of unexpected extubations

    Time frame: up to 28 days

    number of patients with unexpected extubation

  3. clinical and biological respiratory parameters

    Time frame: 24 hours

    description of abnormal clinical and biological respiratory parameters, number of patients concerned.

  4. incidence of mechanical ventilation related complications

    Time frame: up to 48 hours after extubation

    collapses, nosocomial pneumonia, respiratory issue requiring an increase of FiO2 and/or PEP.

  5. incidence of adverse events, related and non related to the treatment

    Time frame: up to 28 days

  6. mortality rate

    Time frame: day 14 and week 6

    mortality rate at day 14 and week 6

  7. factors associated to weaning failure

    Time frame: up to 28 days

    age, patient medical history,duration of sedation or ventilation, weaning failure

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: Sevralox

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 2, 2010
Registry last updated
Jul 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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