Skip to content

Re-evaluation of Midazolam’s Objective Value by Exclusion

In intubated patients in the intensive care unit, does introducing a unit protocol that restricts the use of midazolam as a sedative used by continuous infusion to a limited set of indications reduce the use of antipsychotic medications and other delirium-sensitive outcomes, in comparison to standard practice in equivalent historical periods.

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000381987
Acronym
REMOVE
Enrollment
250
Registered
2011-04-13
Start date
2011-02-07
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

None listed

Brief summary

There is abundant observational evidence that midazolam, a benzodiazepine drug used for sedation, use is associated with delirium in ICU patients. However, despite the availability of an equally effective alternative, benzodiazepines usage remains high. The most likely explanation for is that clinicians are not sufficiently convinced by the quality of the observational studies. This is a reasonable criticism, as it is unlikely that it was possible to adjust for all sources of indication bias in these studies. We hypothesise that introducing a clinical guideline for intubated patients in the Austin Hospital ICU that restricts midazolam use to patients with one of a select list of indications will a. reduce the use of midazolam and b. reduce the incidence of surrogate markers of delirium in ICU patients, without c. significantly increasing cost of sedative medications in the ICU.

Interventions

A clinical guideline for intubated patients in the ICU that restricts continuous IV midazolam use to patients with one of a select list of indications: seizures, alcohol withdrawal, requirement for dangerously high doses of other sedatives. The rate of midazolam infusion under these circumstances will be determined by the physician responsible for the patient's ICU management, using standard clinical assessments to measure response, for the duration judged clincially appropriate.

Sponsors

Austin Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All mechanically ventilated patients admitted to the ICU in the study period

Exclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026