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New sedative may offer better peace in final days

NCT ID NCT05085873

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 sodium oxybate works better than midazolam for providing comfort sedation to people in the final days of life. It involved 22 patients in a palliative care unit who were suffering despite the best standard care. The goal was to see which drug more effectively and consistently kept patients in a deeply calm, pain-free state.

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

22 people

The number who actually took part.

Started

Oct 2021

Finished

Oct 2023

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: * patient hospitalized in a palliative care unit * patient aged 18 or over * patient with an estimated vital prognosis of a few hours to a few days\* * patient with persistent suffering despite optimal palliative care\* * patient gave informed consent in advance or if unable to do so, consent given by a family member or legal representative (patients under guardianship) * patient covered by a social security scheme. \* Validated after collegial and multidisciplinary discussion including the opinion of a doctor outside the palliative care team. Exclusion Criteria: * contraindication or known allergy to sodium oxybate or midazolam * significant risk of seizure * venous access not possible * pregnancy or breastfeeding * person in exclusion period from another research protocol at the time of consent signing * any condition which in the investigator's opinion could increase and jeopardize persons safety in case of research participation

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Conditions

The condition(s) this trial relates to.

Death

As listed by the trial registrant

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

Contacts and locations

Locations

  • Centre Hospitalier Princesse Grace

    Monaco, 98000, Monaco

More trials for these conditions

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