Effectiveness and Safety Study of Etomidate Versus Midazolam to Help Place a Breathing Tube Outside of the Hospital.
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Purpose
The objective of this study was to compare the utility of etomidate and midazolam in helping patients to relax when there was a need for the placement of a ventilation tube by medics who were transporting patients to a hospital in an ambulance.
| Condition | Intervention | Phase |
|---|---|---|
|
Respiratory Failure |
Drug: Etomidate (20mg) or Midazolam (7mg) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Etomidate Versus Midazolam for Pre-Hospital Intubation: A Prospective, Randomized Trial |
| Study Start Date: | October 2002 |
| Estimated Study Completion Date: | November 2005 |
Study Objective: The objective of this study was to compare the utility of etomidate and midazolam for sedative facilitated intubation (SFI), without paralytics, in pre-hospital adult patients.
Methods: This prospective, double-blind, randomized trial was conducted with two ground pre-hospital Advanced Life Support (ALS) units. All patients age 18 or over transported by the two participating systems requiring pre-hospital SFI were eligible for participation. The ambulances were stocked with blinded numbered syringes, each containing either 7mg of midazolam or 20mg of etomidate. Contact with the Medic Command physician was not required and no paralytics were used. If sedation was not achieved with the study drug, medics could request additional sedation from a Medical command physician; only midazolam or diazepam were available outside of the study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Under the study protocol, all patients age 18 or over transported by the two participating ALS systems, requiring pre-hospital Sedation Facilitated Intubation, were eligible for participation.
Exclusion Criteria:
Exclusion criteria were pregnancy and age less than 18.
Contacts and Locations| United States, Pennsylvania | |
| St. Luke's Hospital | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Principal Investigator: | Jeanne L Jacoby, MD | St Luke's Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00248729 History of Changes |
| Other Study ID Numbers: | SLHN 001 |
| Study First Received: | November 2, 2005 |
| Last Updated: | August 28, 2006 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases Midazolam Etomidate 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 |
ClinicalTrials.gov processed this record on June 17, 2013