Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures

Inclusion Criteria:

   - Signed informed consent form and/or assent and willingness of patient and parent(s) to
   participate in the trial.

   - In US sites: Paediatric male or female patients, aged ≥3 and <18 years scheduled to
   undergo a diagnostic or therapeutic procedure, which is medically indicated and
   independent from the trial.

   - In European sites: Paediatric male or female patients, aged full term birth to <18
   years scheduled to undergo a diagnostic or therapeutic procedure, which is medically
   indicated and independent from the trial.

   - Maximum planned duration of procedure: 2 hours

   - ASA Physical Status I-III

   - Planned spontaneous breathing during sedation

   - A female who is of child bearing potential (i.e. after menarche) and sexually active
   must use a highly effective method of birth control during the trial period (from the
   time of consent until all specified observations are completed)

   - Negative pregnancy test at screening and on treatment day -

Exclusion Criteria:

   - Emergency procedures

   - Condition/procedure that requires planned airway control via endotracheal tube or
   LMA/IGEL insertion

   - Cranio-facial malformation, which would severely limit the possibilities for emergency
   airway rescue

   - Other abnormalities relating to the airway (including large tonsils and anatomical
   abnormalities of upper airway or lower airway) which may compromise emergency airway
   rescue

   - Known hypersensitivity to benzodiazepines, flumazenil, dextran or any of the
   ingredients of the drug product

   - Known paradoxical reactions to benzodiazepines

   - History of sleep apnoea

   - Active respiratory failure

   - Active neuromuscular disease

   - Active cardiac failure

   - Active hepatic failure

   - Breast feeding females

   - Prohibited medication

   - Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be
   inappropriate for the trial for any other reason