A Phase 4 interventional study of Sodium Oxybate injection and Midazolam injection in Palliative Care, sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. Completed at 1 site in Monaco. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Phase 4, Interventional, and Supportive care
The study aims at deepen the proof level of sodium oxybate use for comfort sedation at the end of life in a palliative care unit by comparing it to midazolam in a prospective randomized study with blinded efficacy evaluation. The study will be carried out for a period of 24 months with a recruitment objective of 22 patients with refractory suffering and with a short-term prognosis.
In certain cases, terminally-ill patients may show persistent symptoms despite numerous efforts to find a comfort treatment without causing impaired consciousness. In these cases and after a collegial discussion, sedation may be offered.
Midazolam is then the most typically used sedative agent. However, it has limitations: frequent awakenings, tolerance and major respiratory depression. Furthermore, the use of midazolam as a "gold standard" in palliative sedation at the end of life falls under expert consensus without a high level of evidence.
Sodium oxybate (GammaOH®), is an ancient molecule used in anesthesia and other medical fields. It appears to be an attractive alternative to midazolam. Study hypothesis is as follows: deep sedation induced by sodium oxybate (RASS: -4 or -5) is more constant and sustainable than by using midazolam which can cause fluctuating effects and requires frequent dosage adjustments. The single-blind clinical trial aims at comparing the possibility to obtain constant deep sedation using midazolam or sodium oxybate. Before the induction, the patient is not aware of the medication used. The medical team must be aware of it because the two administration procedures are too different.
456 studies on the registry are indexed under Death; 86 are open to participants now.
This study's enrollment of 22 is below the median of 163 across 210 interventional studies indexed under Death.
Browse Death studies →Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer is the lead sponsor of 78 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Sodium Oxybate injection
Drug: Midazolam injection
* Induction dosage : 60 mg/kg by direct intravenous injection. * Continuous dosage : 45 mg/kg/h by continuous intravenous injection. * Additional dosage if the Richmond Agitation Sedation Scale (RASS) score exceeds -4 : 1000 mg sodium oxybate by direct intravenous injection bolus every hour at most until RASS score reaches -4. Sedation maintained until patient death.
Also known as: Gamma-Hydroxybutyric acid, 4-hydroxybutanoic acid
* Induction dosage : 1 mg every 3 min by direct intravenous injection until RASS score reaches -4 (with a maximum of 30 min). * Continuous dosage : Half of titration dosage every hour by continuous intravenous injection. * Additional dosage if the RASS score exceeds -4 : 1 mg every 3 min by direct intravenous injection (without exceeding 10 mg/h). Sedation maintained until patient death.
Reaching and maintaining a comfort sedation defined by a target RASS score of -4
Treatment is defined as successful when reaching and consistently maintaining the target score; treatment is defined as not successful when not reaching the target score at induction or not maintaining a score of \<= -4 for patients who initially reached the target.
Time frame: From inclusion until death, up to 12 hours
Adverse events
Number of clinical adverse events recorded in both arms.
Time frame: From inclusion until death, up to 12 hours
Survival time
Time span between induction of sedation and death.
Time frame: From inclusion until death, up to 12 hours
Plan to share: No
Ran from Oct 2021 to primary completion in Oct 2023, 23 months.
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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sodium Oxybate
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer