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Completed

NCT Number: NCT05085873

Sodium Oxybate Versus Midazolam for Comfort Sedation

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.

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Key information

Conditions

Palliative Care Death Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Hospitalier Princesse Grace

Monaco, 98000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Gamma-Hydroxybutyric acid, 4-hydroxybutanoic acid

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Adverse events

    Time frame: From inclusion until death, up to 12 hours

    Number of clinical adverse events recorded in both arms.

  2. Survival time

    Time frame: From inclusion until death, up to 12 hours

    Time span between induction of sedation and death.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Registry information

Acronym: ONAMI

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 20, 2021
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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