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New combo sedation aims to calm recovery agitation

NCT ID NCT01544725

Symptom relief Sponsor: Centre Hospitalier Universitaire de Nice 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether combining ketamine with propofol reduces agitation during recovery from sedation, compared to ketamine alone. 150 adults needing sedation for a broken bone or dislocation were randomly assigned to one of the two drug combinations. The main goal was to see how many patients experienced recovery agitation, with secondary checks on breathing problems, blood pressure changes, and sedation duration.

What this could mean

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

Active substance
ketamine and propofol
What this could lead to
If successful, this combination could make emergency procedures more comfortable for adults by reducing agitation during recovery.
What could go wrong
This is a small, completed Phase 4 trial with 150 participants, so results may not apply to all patients or settings. The combination may also carry its own side effects.

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

150 people

The number who actually took part.

Start date

Apr 2012

Finished

Jan 2016

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: * 18 years and older * indication of procedural sedation Exclusion Criteria: * allergy to propofol or ketamine * alcohol or drug intoxication * altered mental status * ASA physical status score \> 2 * hemodynamic unstability

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Conditions

The condition(s) this trial relates to.

bone fracture Joint Dislocations

As listed by the trial registrant

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

Dislocation Fracture

Contacts and locations

Locations

  • Hôpital St Roch

    Nice, 06006, France

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