drugset / Trial / NCT05085873
Sodium Oxybate Versus Midazolam for Comfort Sedation
RandomizedParallel-groupSingle-blindSupportive care
Summary
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.
Timeline
- Start
- 2021-10-14
- Primary completion
- 2023-10-10
- Completion
- 2023-10-10
Publications
- 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Midazolam | Small molecule | 1 mg | Intravenous |
| Subject | Sodium Oxybate | Unknown | 45 mg/kg | Intravenous |
Indications
No indication recorded.