Sodium Oxybate Versus Midazolam for Comfort Sedation

NCT05085873 | Completed Phase 4 DMC

• 2 other identifiers: 2020-CHITS-0022021-001961-19
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Palliative Care

Keywords

Sedation; End-of-life; Palliative care; Midazolam; Sodium oxybate

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Adverse events

  From inclusion until death, up to 12 hours

• Survival time

  From inclusion until death, up to 12 hours

Study Arms (2)

Sodium oxybate

EXPERIMENTAL

Drug: Sodium Oxybate injection

Midazolam

ACTIVE COMPARATOR

Drug: Midazolam injection

Interventions

Sodium Oxybate injection DRUG

* 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

Sodium oxybate

Midazolam injection DRUG

* 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.

Midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• contraindication or known allergy to sodium oxybate or midazolam
• significant risk of seizure
• venous access not possible
• pregnancy or breastfeeding
• any condition which in the investigator's opinion could increase and jeopardize persons safety in case of research participation

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (1)

Centre Hospitalier Princesse Grace

Monaco, 98000, Monaco

Location

Related Publications (2)

• 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.

  PMID: 26302340 BACKGROUND

• 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.

  PMID: 41429434 RESULT

MeSH Terms

Conditions

Death

Interventions

Sodium Oxybate; 4-hydroxybutyric acid; Midazolam

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxybutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jean-François CIAIS, MD

  Centre Hospitalier Princesse Grace - Monaco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants won't be aware of the sedative treatment administered.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 20, 2021
• Study Start: October 14, 2021
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: January 26, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)