Conscious sedation is an altered level of consciousness that still allows a patient to respond to physical stimulation and verbal commands. The purpose of conscious sedation is to produce a state of relaxation to facilitate performing medical, diagnostic and surgical procedures. Midazolam is approved worldwide for this indication in all age groups.
Conscious sedation is mainly used in 2 settings:
- Procedural sedation = to induce anxiolysis, amnesia and sedation in patients that will undergo a relative simple, short but sometimes unpleasant procedure (e.g. endoscopy, placements of drains or catheters, ENT interventions). The purpose is that the patient will allow and tolerate the procedure and that the procedure as such can be performed in a safe and successful way. Most often applied in hospitals in an outpatient setting.
- Premedication = to reduce anxiety and apprehension and to induce sedation in patients that will be administered an anaesthetic near upon, as they need to undergo a (major) surgical procedure. The purpose is to prepare the patient for anaesthesia and to provide optimal conditions for surgery.Currently anxious patients need to get midazolam by injection, which can be painful and the use of a needle potentially will increase the state of anxiety, especially in children. Tablets containing midazolam are hardly used (only in children) due to the high variability in onset of action and metabolism between individuals, which makes it very unpredictable when the sedation will start and how long it will last. As a result, procedures are hard to plan/manage. Alternatively, anxious patients are not treated at all (if an option) or are completely sedated for which an anaesthesiologist needs to be present.
Due to the elegant and painless way of administrating a nasal spray, anxious people can always be treated now. As the onset of action (only minutes) and the duration (approx. half an hour) of the sedation are known, procedures can be planned.
The product will be applicable in children and adults. The main areas where the nasal spray could be utilized is:
- Procedural sedation in hospital/outpatient setting, e.g. endoscopies (colon, gastro-intestinal, respiratory, urinary), MRI/CT-scans (relief of claustrophobia), fracture and wound care, change of dressing, placements of drains and catherters, in gynaecology, paediatrics, ophthalmology (examinations and procedures e.g. eye lasering), ENT, oncology, minor biopsy procedures, at the oncology-, orthopaedic- (fracture treatment), emergency- and in outpatient departments and
- Procedural sedation outside a hospital, e.g. in dentistry, GP′s