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Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures
Not Recruiting
Trial ID: NCT04851717
Purpose
To assess the efficacy of intravenous remimazolam in inducing and maintaining suitable
sedation levels for paediatric patients undergoing diagnostic and/or therapeutic procedures
Official Title
A Phase 2/3, Prospective, Open-label Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of Remimazolam for Intravenous Sedation in Paediatric Patients Undergoing Diagnostic and/or Therapeutic Procedures
Stanford Investigator(s)
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
Intervention(s):
drug: Remimazolam
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305