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Sodium Oxybate Versus Midazolam for Comfort Sedation

NCT05085873 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-01-26

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

    lead OTHER

Principal Investigators

  • Jean-François CIAIS, MD · Centre Hospitalier Princesse Grace - Monaco

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-14
Primary Completion
2023-10-10
Completion
2023-10-10

Countries

  • Monaco

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05085873 on ClinicalTrials.gov