Sodium Oxybate Versus Midazolam for Comfort Sedation

PHASE4CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

October 14, 2021

Primary Completion Date

October 10, 2023

Study Completion Date

October 10, 2023

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."

Trial Locations (1)

98000

Centre Hospitalier Princesse Grace, Monaco

All Listed Sponsors
lead

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

OTHER

NCT05085873 - Sodium Oxybate Versus Midazolam for Comfort Sedation | Biotech Hunter | Biotech Hunter