BridgeMD
The sedative effects and local tolerability of nasal administration of remimazolam using a Soft Mist Nasal Administration Device
EU CTIS ID: 2024-516493-30-01
What this study is testing
In this study two dosages of 20 mg remimazolam, adding up to a total dose of 40 mg, will be administered intranasally using a specific nasal atomizer (NAA). Preceding the administration of remimazolam, the nasal mucosa will be locally anesthetized with 20 mg lidocaine, also applicated with a nasal atomizer, to prevent local irritation. We will evaluate the sedative effect and the comfort level for the subjects.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age between 18-60 years
- Lean body weight >= 50 kg
- ASA physical status class I
You likely can't join if
- • Inability to cooperate
- • Predicted difficult airway
- • Obstruction of nasal passage at either side
- • Chronic rhinitis
- • Chronic sinusitis
- • (Possible) pregnancy
See the full eligibility criteria
- Age between 18-60 years
- Lean body weight >= 50 kg
- ASA physical status class I
- • Inability to cooperate
- • Predicted difficult airway
- • Obstruction of nasal passage at either side
- • Chronic rhinitis
- • Chronic sinusitis
- • (Possible) pregnancy
- • Breast feeding women
- • No written informed consent by subject
- • History of hepatic, renal and coagulation diseases
- • History of epileptic insult
- • Allergy to any of the study drug concipients
- • Use of benzodiazepines in the 4 weeks preceding IMP administration
- • Nasal medication use in the 4 weeks preceding IMP administration
- • Alcohol and drugs misuse in the 2 weeks preceding IMP administration
- • Alcohol use during 24 hours preceding IMP administration
- • Respiratory tract pathology
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.