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

NCT00290082 | Terminated Phase 3 DMC

• 2 other identifiers: 2004/055/HPFrench state grant
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

Acute Agitated Patients

Keywords

sedation; midazolam; loxapine; agitation; emergency department; toxicological analysis

Outcome Measures

Primary Outcomes (1)

• Success of treatment at 20 min

  20 min

Secondary Outcomes (5)

• Success of treatment at 40 and 60 min

  40 and 60 mn

• Agitation level at 20,40 and 60 min

  20, 40 and 60mn

• Need for rescue medication

  any time

• Sedation duration

• treatment failure

  one hour after treatment

Study Arms (2)

loxapine

ACTIVE COMPARATOR

agitated patients were randomly assigned either to loxapine, either to midazolam group

Drug: loxapine, midazolam; Biological: blood sample; Other: patient monitoring; Drug: Loxapine

midazolam

ACTIVE COMPARATOR

midazolam is compared to loxapine in terms of efficacy and tolerance

Drug: loxapine, midazolam; Biological: blood sample; Other: patient monitoring; Drug: Midazolam

Interventions

loxapine, midazolam DRUG

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)

Also known as: Loxapac, Hypnovel

loxapine; midazolam

blood sample BIOLOGICAL

was evaluated in patients sedated, alcohol level, blood sugar

Also known as: Loxapac, Hypnovel

loxapine; midazolam

patient monitoring OTHER

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.

loxapine; midazolam

Loxapine DRUG

Loxapine 1 mL / 10 kg

loxapine

Midazolam DRUG

Midazolam 1 mL / 10 Kg

midazolam

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (21)

Emergency Department

Créteil, Paris, France

Location

Emergency Department

Ghps, Paris, France

Location

Emergency Department

Agen, 47923, France

Location

Emergecy department

Argenteuil, 95100, France

Location

Emergency Department

Bayeux, 74401, France

Location

Emergency Department

Bondy, 93143, France

Location

Emergency Department

Carcassonne, 11890, France

Location

Emergency Department

Clermont-Ferrand, 63003, France

Location

Emergency Department

Dijon, 11890, France

Location

Emergency Department

Elbeuf, 76503, France

Location

Emergency Department

Grenoble, 38043, France

Location

Emergency Department

Le Havre, France

Location

Emergency Department

Le Kremlin-Bicêtre, 94275, France

Location

Emergency Department

Le Mans, 72037, France

Location

Emergency Department

Lisieux, 97223, France

Location

Emergency Department

Montauban, 82013, France

Location

Emergency Department

Nantes, 44093, France

Location

Emergency Department

Pontoise, 95301, France

Location

Emergency Department

Raincy-Montfermeil, 93370, France

Location

Emergency Department

Roanne, 43328, France

Location

Emergency Department

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Psychomotor Agitation; Emergencies

Interventions

Loxapine; Midazolam; Blood Specimen Collection; Remote Patient Monitoring

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; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Dibenzoxazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Fabienne FM Moritz, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 10, 2006
• Study Start: December 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

FR (21)