Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06330584
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-03-06
Brief Title:
Administration of Intranasal Midazolam for Anxiety in Palliative Care
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Administration of Intranasal Midazolam for Anxiety in Palliative Care - a Double-blind Randomized Placebo-controlled Multicenter Exploratory Pilot Study With a Nested Pharmacokinetic Analysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIM Care
Brief Summary:
The goal of this double-blind randomized placebo-controlled parallel-group multicenter exploratory pilot study three study arms is to describe effects and safety of different doses of intranasal midazolam to treat acute anxiety in palliative care patients while providing pharmacokinetic and pharmacodynamic data
Detailed Description:
36 patients 12 per study arm will be enrolled All patients hospitalized at the three study sites which are prescribed intranasal midazolam in their as-needed drug regimen and who meet inclusion criteria are eligible Patients will be asked for consent at the time of prescription of midazolam by the attending physician Patients who have provided consent and have been randomized to one of the arms will be included block randomization
In a nested analysis pharmacokinetic properties of all three doses will be analyzed in participants with available venous access
The primary outcome is the change in patient-reported levels of anxiety from baseline Secondary outcomes include time until first requested additional dose cumulative number of doses including time points of administration after the first application oxygen saturation heart rate cortisol levels in oral fluid levels of sedation on the Richmond Agitation Sedation Scale Palliative Version RASS-PAL and occurrence of serious adverse events
The primary and secondary outcomes will be assessed at baseline ie immediately before the intervention 0 minutes and 30 minutes after the intervention The secondary outcomes Time to first requested additional dose and Cumulative number of doses over 24 hours as well as serious adverse events will be assessed starting 30 minutes after the intervention up to 24 hours after the intervention
In patients included in the nested pharmacokinetic analysis basic pharmacokinetic parameters will additionally be assessed at 10 time points starting at baseline 0 minutes up to 240 minutes after the intervention
In a nested analysis pharmacokinetic properties of all three doses will be analyzed in participants with available venous access
The primary outcome is the change in patient-reported levels of anxiety from baseline Secondary outcomes include time until first requested additional dose cumulative number of doses including time points of administration after the first application oxygen saturation heart rate cortisol levels in oral fluid levels of sedation on the Richmond Agitation Sedation Scale Palliative Version RASS-PAL and occurrence of serious adverse events
The primary and secondary outcomes will be assessed at baseline ie immediately before the intervention 0 minutes and 30 minutes after the intervention The secondary outcomes Time to first requested additional dose and Cumulative number of doses over 24 hours as well as serious adverse events will be assessed starting 30 minutes after the intervention up to 24 hours after the intervention
In patients included in the nested pharmacokinetic analysis basic pharmacokinetic parameters will additionally be assessed at 10 time points starting at baseline 0 minutes up to 240 minutes after the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None