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Effectiveness and Safety Study of Etomidate Versus Midazolam to Help Place a Breathing Tube Outside of the Hospital.

Etomidate Versus Midazolam for Pre-Hospital Intubation: A Prospective, Randomized Trial

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00248729
Enrollment
Unknown
Registered
2005-11-04
Start date
2002-10-31
Completion date
2005-11-30
Last updated
2025-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Brief summary

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.

Detailed description

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.

Interventions

DRUGEtomidate (20mg) or Midazolam (7mg)

Sponsors

St. Luke's Hospital, Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026