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.
Sodium Oxybate Versus Midazolam for Comfort Sedation
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.
Intervention / Treatment
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Sodium Oxybate injection (DRUG)* 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.
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Midazolam injection (DRUG)* 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.
Condition or Disease
- Palliative Care
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Recruiting |
| Study results: | No Results Available |
| Age: | 18 Years and older  (Adult, Older Adult) |
| Enrollment: | 22 (ESTIMATED) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Supportive Care |
MaskingParticipants won't be aware of the sedative treatment administered. SINGLE:
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Clinical Trial Dates
| Start date: | Oct 14, 2021 | ACTUAL |
|---|---|---|
| Primary Completion: | Oct 01, 2023 | ESTIMATED |
| Completion Date: | Oct 01, 2023 | ESTIMATED |
| Study First Posted: | Oct 20, 2021 | ACTUAL |
| Last Updated: | Mar 20, 2023 |
Sponsors / Collaborators
Lead sponsor is responsible party
Responsible Party:
N/A
Location
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.
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.
Participant Groups
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No description provided
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No description provided
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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
* 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
This clinical trial is recruiting
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Primary Outcomes
Secondary Outcomes
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Number of clinical adverse events recorded in both arms.
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Time span between induction of sedation and death.
More Details
| NCT Number: | NCT05085873 |
|---|---|
| Acronym: | ONAMI |
| Other IDs: | 2020-CHITS-002 |
| Study URL: | https://clinicaltrials.gov/study/NCT05085873 |
Last updated: Sep 29, 2023