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

March 10, 2015 updated by: University Hospital, Rouen

Comparison Between Midazolam and Loxapine in the Treatment of Agitated Patients in the Emergency Department

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Agen, France, 47923
        • Emergency department
      • Argenteuil, France, 95100
        • Emergecy 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
        • Emergency department
    • Paris
      • Creteil, Paris, France
        • Emergency department
      • Ghps, Paris, France
        • Emergency department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Hypnovel
  • Loxapac
Biological: blood sample
was evaluated in patients sedated, alcohol level, blood sugar
Other Names:
  • Hypnovel
  • Loxapac
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:
  • Hypnovel
  • Loxapac
Biological: blood sample
was evaluated in patients sedated, alcohol level, blood sugar
Other Names:
  • Hypnovel
  • Loxapac
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success of treatment at 20 min
Time Frame: 20 min
20 min

Secondary Outcome Measures

Outcome Measure
Time Frame
Success of treatment at 40 and 60 min
Time Frame: 40 and 60 mn
40 and 60 mn
Agitation level at 20,40 and 60 min
Time Frame: 20, 40 and 60mn
20, 40 and 60mn
Need for rescue medication
Time Frame: any time
any time
Sedation duration
treatment failure
Time Frame: one hour after treatment
one hour after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Fabienne FM Moritz, MD, University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

February 9, 2006

First Submitted That Met QC Criteria

February 9, 2006

First Posted (Estimate)

February 10, 2006

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004/055/HP
  • French state grant

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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