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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001961-19 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium oxybate | Experimental |
| |
| Midazolam | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Oxybate injection | Drug |
Sedation maintained until patient death. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From inclusion until death, up to 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of clinical adverse events recorded in both arms. | From inclusion until death, up to 12 hours |
| Survival time | Time span between induction of sedation and death. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-François CIAIS, MD | Centre Hospitalier Princesse Grace - Monaco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Princesse Grace | Monaco | 98000 | Monaco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26302340 | Background | Ciais JF, Jacquin PH, Pradier C, Castelli-Prieto M, Baudin S, Tremellat F. Using Sodium Oxybate (Gamma Hydroxybutyric Acid) for Deep Sedation at the End of Life. J Palliat Med. 2015 Oct;18(10):822. doi: 10.1089/jpm.2015.0221. Epub 2015 Aug 24. No abstract available. | |
| 41429434 | Result | Ciais JF, Jacquin PH, Gac Marrec A, Decorbez A, Saudemont G, Dugourd C, Berthier F, Payen D. Sodium oxybate versus midazolam for end-of-life continuous deep sedation: a randomised controlled trial. BMJ Support Palliat Care. 2025 Dec 21:spcare-2025-005747. doi: 10.1136/spcare-2025-005747. Online ahead of print. |
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| ID | Term |
|---|---|
| D003643 | Death |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012978 | Sodium Oxybate |
| C111420 | 4-hydroxybutyric acid |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D006885 | Hydroxybutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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Participants won't be aware of the sedative treatment administered.
|
|
| Midazolam injection | Drug |
Sedation maintained until patient death. |
|
| From inclusion until death, up to 12 hours |
| D009930 |
| Organic Chemicals |
| D006880 | Hydroxy Acids |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |