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| Sponsor: | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00122733 |
Purpose
Patients may be very agitated during the weaning period from mechanical ventilation. Administration of loxapine, a neuroleptic that does not notably affect ventilatory drive, may help in obtaining an adequate level of cooperation and, therefore, in reducing the duration of mechanical ventilation.
| Condition | Intervention |
|---|---|
|
Respiratory Insufficiency Psychomotor Agitation |
Drug: loxapine |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Facilitation of Weaning From Ventilator by Loxapine |
| Enrollment: | 9 |
| Study Start Date: | December 2005 |
| Study Completion Date: | December 2006 |
Mechanical ventilation is a life-saving procedure in critically ill patients. This procedure is however not devoid of risks and every effort should be made to shorten its duration. This is best accomplished by the implementation of weaning protocols. Sedation (by opiates and benzodiazepines) is often required in such patients for their comfort and adaptation to the respirator. Withdrawal of sedation in order to allow patients to resume spontaneous breathing may be associated with agitation and confusion that may hinder weaning. In such cases, reinstitution of heavy sedation will prolong ventilator-dependency. It may therefore be interesting to administer a neuroleptic (loxapine) with good anxiolytic properties but that does not notably interfere with spontaneous breathing ability.
Patients will be included when they fail a spontaneous ventilation trial (see inclusion criteria) because of marked agitation. Usual simple clinical (respiratory frequency, P01 measured on the respirator, arterial pressure, cardiac rate) and biological criteria (arterial blood gas determination) and a measurement of sedation/agitation with validated scales (Richmond agitation sedation scale, Ramsay score) will be gathered when a patient is deemed ready for a trial of spontaneous ventilation for weaning. In cases of marked agitation according to validated scales, patients will be given a conventional dose (150 mg) of loxapine by the nasogastric tube and the efficacy of this treatment will be evaluated on the same parameters as above. Demonstration of the facilitation of weaning by this simple strategy would be useful in order to reduce risks associated with mechanical ventilation.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| France | |
| Service de Réanimation, Hopital Louis Mourier | |
| Colombes, France, 92700 | |
| Principal Investigator: | Guillaume CHEVREL, MD | Assistance Publique - Hôpitaux de Paris |
More Information
| Study ID Numbers: | LMR2 |
| Study First Received: | July 19, 2005 |
| Last Updated: | July 20, 2007 |
| ClinicalTrials.gov Identifier: | NCT00122733 History of Changes |
| Health Authority: | France: Ministry of Health |
|
Mechanical ventilation Agitation Difficult weaning |
|
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Respiration Disorders Nervous System Diseases Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists Psychomotor Agitation Antipsychotic Agents Dyskinesias |
Pharmacologic Actions Signs and Symptoms Respiratory Insufficiency Respiratory Tract Diseases Therapeutic Uses Psychomotor Disorders Loxapine Neurologic Manifestations Dopamine Agents Central Nervous System Agents Neurobehavioral Manifestations |