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

Primary Purpose

Acute Agitated Patients

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
loxapine, midazolam
blood sample
patient monitoring
Loxapine
Midazolam
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Agitated Patients focused on measuring sedation, midazolam, loxapine, agitation, emergency department, toxicological analysis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emergency Department
  • Emergency Department
  • Emergency Department
  • Emergecy department
  • Emergency Department
  • Emergency Department
  • Emergency Department
  • Emergency Department
  • Emergency Department
  • Emergency Department
  • Emergency Department
  • Emergency Department
  • Emergency Department
  • Emergency Department
  • Emergency Department
  • Emergency Department
  • Emergency Department
  • Emergency Department
  • Emergency Department
  • Emergency Department
  • Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

loxapine

midazolam

Arm Description

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

midazolam is compared to loxapine in terms of efficacy and tolerance

Outcomes

Primary Outcome Measures

Success of treatment at 20 min

Secondary Outcome Measures

Success of treatment at 40 and 60 min
Agitation level at 20,40 and 60 min
Need for rescue medication
Sedation duration
treatment failure

Full Information

First Posted
February 9, 2006
Last Updated
March 10, 2015
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT00290082
Brief Title
Randomized Double-blind Trial of Midazolam and Loxapine in Agitated Patients
Official Title
Comparison Between Midazolam and Loxapine in the Treatment of Agitated Patients in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
2 complications with midazolam
Study Start Date
December 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Agitated Patients
Keywords
sedation, midazolam, loxapine, agitation, emergency department, toxicological analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
loxapine
Arm Type
Active Comparator
Arm Description
agitated patients were randomly assigned either to loxapine, either to midazolam group
Arm Title
midazolam
Arm Type
Active Comparator
Arm Description
midazolam is compared to loxapine in terms of efficacy and tolerance
Intervention Type
Drug
Intervention Name(s)
loxapine, midazolam
Other Intervention Name(s)
Loxapac, Hypnovel
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
blood sample
Other Intervention Name(s)
Loxapac, Hypnovel
Intervention Description
was evaluated in patients sedated, alcohol level, blood sugar
Intervention Type
Other
Intervention Name(s)
patient monitoring
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Loxapine
Intervention Description
Loxapine 1 mL / 10 kg
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Midazolam 1 mL / 10 Kg
Primary Outcome Measure Information:
Title
Success of treatment at 20 min
Time Frame
20 min
Secondary Outcome Measure Information:
Title
Success of treatment at 40 and 60 min
Time Frame
40 and 60 mn
Title
Agitation level at 20,40 and 60 min
Time Frame
20, 40 and 60mn
Title
Need for rescue medication
Time Frame
any time
Title
Sedation duration
Title
treatment failure
Time Frame
one hour after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabienne FM Moritz, MD
Organizational Affiliation
University Hospital, Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency Department
City
Creteil
State/Province
Paris
Country
France
Facility Name
Emergency Department
City
Ghps
State/Province
Paris
Country
France
Facility Name
Emergency Department
City
Agen
ZIP/Postal Code
47923
Country
France
Facility Name
Emergecy department
City
Argenteuil
ZIP/Postal Code
95100
Country
France
Facility Name
Emergency Department
City
Bayeux
ZIP/Postal Code
74401
Country
France
Facility Name
Emergency Department
City
Bondy
ZIP/Postal Code
93143
Country
France
Facility Name
Emergency Department
City
Carcassonne
ZIP/Postal Code
11890
Country
France
Facility Name
Emergency Department
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Emergency Department
City
Dijon
ZIP/Postal Code
11890
Country
France
Facility Name
Emergency Department
City
Elbeuf
ZIP/Postal Code
76503
Country
France
Facility Name
Emergency Department
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Emergency Department
City
Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Emergency Department
City
Le Havre
Country
France
Facility Name
Emergency Department
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Emergency Department
City
Lisieux
ZIP/Postal Code
97223
Country
France
Facility Name
Emergency Department
City
Montauban
ZIP/Postal Code
82013
Country
France
Facility Name
Emergency Department
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Emergency Department
City
Pontoise
ZIP/Postal Code
95301
Country
France
Facility Name
Emergency Department
City
Raincy-Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
Emergency Department
City
Roanne
ZIP/Postal Code
43328
Country
France
Facility Name
Emergency Department
City
St Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

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

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