Sodium Oxybate Versus Midazolam for Comfort Sedation

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Treatments: Midazolam; Sodium Oxybate

Criteria

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