Randomized Double-blind Trial of Midazolam and Loxapine in Agitated Patients

This study has been terminated.
(2 complications with midazolam)
Sponsor:
Information provided by:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00290082
First received: February 9, 2006
Last updated: March 22, 2010
Last verified: March 2010
  Purpose

Neuroleptics are used since a long time in the management of severely agitated patients. Loxapine is routinely used in our country, with, to our knowledge no severe adverse event reported, in this indication.

However, recently, benzodiazepines have appeared interesting in agitated patients, with the use of midazolam.

The aim of this study is to compare midazolam to loxapine in the treatment of severe agitated patients admitted in the emergency department.


Condition Intervention Phase
Acute Agitated Patients
Drug: loxapine, midazolam
Biological: blood sample
Other: patient monitoring
Drug: Loxapine
Drug: Midazolam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Midazolam and Loxapine in the Treatment of Agitated Patients in the Emergency Department

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Success of treatment at 20 min [ Time Frame: 20 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Success of treatment at 40 and 60 min [ Time Frame: 40 and 60 mn ] [ Designated as safety issue: No ]
  • Agitation level at 20,40 and 60 min [ Time Frame: 20, 40 and 60mn ] [ Designated as safety issue: No ]
  • Need for rescue medication [ Time Frame: any time ] [ Designated as safety issue: No ]
  • Sedation duration [ Time Frame: not available ] [ Designated as safety issue: No ]
  • treatment failure [ Time Frame: one hour after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: December 2005
Estimated Study Completion Date: October 2007
Estimated Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: loxapine
agitated patients were randomly assigned either to loxapine, either to midazolam group
Drug: loxapine, midazolam
agitated patients received loxapine 1 ml/ kg body weight ( loxapine 25mg/ml) or midazolam 1 ml/ kg body weight ( midazolam 1mg/ml) if patients were still agitated 20 min after the first treatment, they received loxapine 0.5 ml/ kg body weight ( loxapine 25mg/ml) or midazolam 0.5 ml/ kg body weight ( midazolam 1mg/ml)
Other Names:
  • Loxapac
  • Hypnovel
Biological: blood sample
was evaluated in patients sedated, alcohol level, blood sugar
Other Names:
  • Loxapac
  • Hypnovel
Other: patient monitoring
Till his coming out the emergency service, patient had an hemodynamic, respiratory and neurologic monitoring as well as an agitated score monitoring The occurence of a complication during the 15 days after leaving the emergency department was prospected.
Drug: Loxapine
Loxapine 1 mL / 10 kg
Active Comparator: midazolam
midazolam is compared to loxapine in terms of efficacy and tolerance
Drug: loxapine, midazolam
agitated patients received loxapine 1 ml/ kg body weight ( loxapine 25mg/ml) or midazolam 1 ml/ kg body weight ( midazolam 1mg/ml) if patients were still agitated 20 min after the first treatment, they received loxapine 0.5 ml/ kg body weight ( loxapine 25mg/ml) or midazolam 0.5 ml/ kg body weight ( midazolam 1mg/ml)
Other Names:
  • Loxapac
  • Hypnovel
Biological: blood sample
was evaluated in patients sedated, alcohol level, blood sugar
Other Names:
  • Loxapac
  • Hypnovel
Other: patient monitoring
Till his coming out the emergency service, patient had an hemodynamic, respiratory and neurologic monitoring as well as an agitated score monitoring The occurence of a complication during the 15 days after leaving the emergency department was prospected.
Drug: Midazolam
Midazolam 1 mL / 10 Kg

Detailed Description:

Prospective, Randomized, Double-blind, Multicenter study (20 french emergency departments)

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Severely agitated patients (Richard Scale over or equal to 5) between 18 and 65 years old

Exclusion Criteria:

Hypoglycemia hypoxemia patients with known dementia blood pressure <90 mmHg known cocaine or amphetamine intoxication pregnancy respiratory or liver insufficiency myasthenia sedation before arrival to hospital

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290082

Locations
France
Emergency Department
Creteil, Paris, France
Emergency Department
Ghps, Paris, France
Emergency Department
Agen, France, 47923
Emergecy department
Argenteuil, France, 95100
Emergency Department
Bayeux, France, 74401
Emergency Department
Bondy, France, 93143
Emergency Department
Carcassonne, France, 11890
Emergency Department
Clermont-ferrand, France, 63003
Emergency Department
Dijon, France, 11890
Emergency Department
Elbeuf, France, 76503
Emergency Department
Grenoble, France, 38043
Emergency Department
Kremlin Bicetre, France, 94275
Emergency Department
Le Havre, France
Emergency Department
Le Mans, France, 72037
Emergency Department
Lisieux, France, 97223
Emergency Department
Montauban, France, 82013
Emergency Department
Nantes, France, 44093
Emergency Department
Pontoise, France, 95301
Emergency Department
Raincy-Montfermeil, France, 93370
Emergency Department
Roanne, France, 43328
Emergency Department
St Etienne, France, 42055
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Fabienne FM Moritz, MD University Hospital, Rouen
  More Information

No publications provided

Responsible Party: CHU-Hopitaux de Rouen, Delegation de la recherche clinique
ClinicalTrials.gov Identifier: NCT00290082     History of Changes
Other Study ID Numbers: 2004/055/HP, French state grant
Study First Received: February 9, 2006
Last Updated: March 22, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
sedation
midazolam
loxapine
agitation
emergency department
toxicological analysis

Additional relevant MeSH terms:
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Midazolam
Loxapine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on April 16, 2014