Sodium Oxybate Versus Midazolam for Comfort Sedation (ONAMI)

January 23, 2026 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Monaco
      • Monaco, Monaco, 98000
        • Centre Hospitalier Princesse Grace

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sodium oxybate
Drug: Sodium Oxybate injection
  • 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
Active Comparator: Midazolam
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From inclusion until death, up to 12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: From inclusion until death, up to 12 hours
Number of clinical adverse events recorded in both arms.
From inclusion until death, up to 12 hours
Survival time
Time Frame: From inclusion until death, up to 12 hours
Time span between induction of sedation and death.
From inclusion until death, up to 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Investigators

  • Study Director: Jean-François CIAIS, MD, Centre Hospitalier Princesse Grace - Monaco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2021

Primary Completion (Actual)

October 10, 2023

Study Completion (Actual)

October 10, 2023

Study Registration Dates

First Submitted

September 23, 2021

First Submitted That Met QC Criteria

October 7, 2021

First Posted (Actual)

October 20, 2021

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-CHITS-002
  • 2021-001961-19 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Palliative Care

Clinical Trials on Sodium Oxybate injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe