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| Sponsor: | St. Luke's Hospital, Pennsylvania |
|---|---|
| Information provided by: | St. Luke's Hospital, Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00248729 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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
| Study ID Numbers: | SLHN 001 |
| Study First Received: | November 2, 2005 |
| Last Updated: | August 28, 2006 |
| ClinicalTrials.gov Identifier: | NCT00248729 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Anesthetics, Intravenous Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Respiration Disorders Physiological Effects of Drugs Psychotropic Drugs Anesthetics Central Nervous System Depressants Midazolam |
Etomidate Pharmacologic Actions Adjuvants, Anesthesia Respiratory Insufficiency Respiratory Tract Diseases Anesthetics, General Therapeutic Uses Hypnotics and Sedatives GABA Agents Anti-Anxiety Agents Central Nervous System Agents |
