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Sedative showdown in TBI: propofol vs midazolam study halted after just one patient

NCT ID NCT01712477

Knowledge-focused Sponsor: Michigan State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study aimed to compare two common sedatives, propofol and midazolam, in patients with traumatic brain injury who needed a breathing tube. Researchers wanted to see if one drug led to better recovery or different levels of inflammation markers called cytokines. However, the trial was terminated early after enrolling only one person, so no meaningful conclusions could be drawn.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
propofol and midazolam

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

1 person

The number who actually took part.

Start date

Nov 2011

Finished

Dec 2014

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Ages 18 Years or older * Males or Females * Primary diagnosis of TBI, subarachnoid hemmorhage (SAH), intracranial hemmorhage (ICH), stroke * Requires mechanical ventilation * Requires or is receiving continuous IV sedation Exclusion Criteria: * Glascow Coma Score (GCS) of 3 persisting from the scene with bilaterally fixed dilated pupils with no appreciable chance of survival * The inability to identify a next of kin or guardian to give consent if patient unable to consent * Pregnant * Allergy or contraindication to propofol * Allergy to contraindication to midalozam * Status epilepticus * Current neuromuscular blockade * Patient with a known hypersensitivity to propofol or midalozam * Allergies to eggs, egg products, soybeans or soy products * Acute narrow-angle glaucoma

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic intracerebral hemorrhage stroke disorder subarachnoid hemorrhage traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Traumatic brain injury

Contacts and locations

Locations

  • Sparrow Health System

    Lansing, Michigan, 48912, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.