Palliative CarePhase 4ONAMINCT05085873
Sodium Oxybate Versus Midazolam for Comfort Sedation
A Phase 4 study testing Sodium Oxybate injection and Midazolam injection in people with Palliative Care, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in Monaco.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care
- What is being tested?
- Sodium Oxybate injection and Midazolam injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteMonaco
- Study dates
- 14 Oct 2021to 10 Oct 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Palliative Care
- Being tested
- Sodium Oxybate injection, Midazolam injection
- Keywords
- Sedation, End-of-life, Palliative care, Midazolam, Sodium oxybate
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Oxybate injectionDrug
Also called Gamma-Hydroxybutyric acid, 4-hydroxybutanoic acid
- 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.
Midazolam injectionDrug
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Sodium oxybate | Experimental | Not described Receives: Drug: Sodium Oxybate injection |
| Midazolam | Active comparator | Not described Receives: Drug: Midazolam injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From inclusion until death, up to 12 hours
Secondary outcomes (2)
Adverse events
Number of clinical adverse events recorded in both arms.
Measured: From inclusion until death, up to 12 hours
Survival time
Time span between induction of sedation and death.
Measured: From inclusion until death, up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start14 Oct 2021
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François CIAIS, MD, Study director, Centre Hospitalier Princesse Grace - Monaco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085873
- Sponsor's protocol ID
- 2020-CHITS-002
- Other IDs
- 2021-001961-19
- Acronym
- ONAMI
- Status last verified
- Nov 2025
- First submitted
- 23 Sep 2021
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26302340Ciais 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.
PubMed 41429434
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Oxybate Versus Midazolam for Comfort Sedation
- ClinicalTrials.gov ID
- NCT05085873
- Acronym / sponsor ID
- ONAMI / 2020-CHITS-002
- Conditions
- Palliative Care
- Keywords
- Sedation, End-of-life, Palliative care, Midazolam, Sodium oxybate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium oxybate | Experimental | Drug: Sodium Oxybate injection |
| Midazolam | Active comparator | Drug: Midazolam injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Oxybate injectionAlso: Gamma-Hydroxybutyric acid, 4-hydroxybutanoic acid* 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. | Drug | Sodium oxybate |
| Midazolam injection* 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. | Drug | Midazolam |
Primary outcome
Reaching and maintaining a comfort sedation defined by a target RASS score of -4
Time frame: From inclusion until death, up to 12 hours
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.
2 secondary outcomes
Adverse events
Time frame: From inclusion until death, up to 12 hours
Survival time
Time frame: From inclusion until death, up to 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Background: PubMed 26302340Ciais 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 publication: PubMed 41429434Ciais 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François CIAIS, MD study director
Centre Hospitalier Princesse Grace - Monaco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Oxybate injection and Midazolam injection in people with Palliative Care, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in Monaco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaching and maintaining a comfort sedation defined by a target RASS score of -4 (time frame: From inclusion until death, up to 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05085873, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.