Clinical trial NCT05085873: Sodium Oxybate Versus Midazolam for Comfort Sedation
Official title: Sodium Oxybate Versus Midazolam for Comfort Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Palliative Care
Keywords: Sedation
End-of-life
Palliative care
Midazolam
Sodium oxybate
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Reaching and maintaining a comfort sedation defined by a target RASS score of -4
timeFrame: From inclusion until death, up to 12 hours
Secondary outcomes:
measure: Adverse events
timeFrame: From inclusion until death, up to 12 hours
measure: Survival time
timeFrame: From inclusion until death, up to 12 hours
Other outcomes:
Locations:
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
affiliation: Centre Hospitalier Princesse Grace - Monaco
name: Jean-François CIAIS, MD
role: STUDY_DIRECTOR
References:
citation: 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.