Trial Search Results

Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures

To assess the efficacy of intravenous remimazolam in inducing and maintaining suitable sedation levels for paediatric patients undergoing diagnostic and/or therapeutic procedures

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Acacia Pharma Ltd

Collaborator: Paion UK Ltd.

Stanford Investigator(s):

Intervention(s):

  • Drug: Remimazolam

Phase:

Phase 2/Phase 3

Eligibility


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

Ages Eligible for Study

N/A - 17 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting