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

Phase 3

Terminated

• Conditions: Acute Agitated Patients
• Interventions: Drug: loxapine, midazolam; Biological: blood sample; Other: patient monitoring; Drug: Loxapine; Drug: Midazolam

• Registration Number: NCT00290082
• Lead Sponsor: University Hospital, Rouen

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)

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-02-09
• Study First Submitted QC: 2006-02-09
• Study First Posted: 2006-02-10
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
loxapine	blood sample	agitated patients were randomly assigned either to loxapine, either to midazolam group
loxapine	patient monitoring	agitated patients were randomly assigned either to loxapine, either to midazolam group
loxapine	Loxapine	agitated patients were randomly assigned either to loxapine, either to midazolam group
midazolam	blood sample	midazolam is compared to loxapine in terms of efficacy and tolerance
loxapine	loxapine, midazolam	agitated patients were randomly assigned either to loxapine, either to midazolam group
midazolam	patient monitoring	midazolam is compared to loxapine in terms of efficacy and tolerance
midazolam	loxapine, midazolam	midazolam is compared to loxapine in terms of efficacy and tolerance
midazolam	Midazolam	midazolam is compared to loxapine in terms of efficacy and tolerance

Primary Outcome Measures

Name	Time	Method
Success of treatment at 20 min	20 min

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Emergency Department; 🇫🇷 St Etienne, France

Emergecy department; 🇫🇷 Argenteuil, France