Paediatric procedural sedation MedDRA version: 23.0 Level: LLT Classification code 10083924 Term: Sedation procedure System Organ Class: 100000004865
Conditions
Interventions
Trade Name: BYFAVO (EU and US) / ANEREM (Japan)
Product Name: Remimazolam
Product Code: CNS 7056B, CNS 7056 besylate, ONO-2745BS, ONO-IN-2
Pharmaceutical Form: Powder for solution for injection/infusi
Sponsors
PAION UK Ltd
Acacia Pharma Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed informed consent form and/or assent (if applicable) and willingness of patient and parent(s) to participate in the trial. • In European sites: Paediatric male or female patients, aged full term birth to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 IMP • Known paradoxical reactions to benzodiazepines • History of sleep apnoea • Active respiratory failure • Active neuromuscular disease • Active cardiac failure • Active hepatic failure • Pregnant or Breast-feeding females • Prohibited medication: ? Any investigational drug when taken within 30 days or less than 7 half-lives (whichever is longer) before Treatment Day. ? Any medication given for sedative purposes other than nitrous oxide and IMP on the Treatment Day ? (For full list of prohibited medication after randomisation please see Protocol) • Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the trial for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of IV remimazolam in inducing and maintaining suitable sedation levels for paediatric patients undergoing diagnostic and/or therapeutic procedures.;Secondary Objective: To evaluate the onset and offset characteristics, the safety, and the PK of IV remimazolam in paediatric patients undergoing diagnostic and/or therapeutic procedures, and to establish dose levels for the different age groups.;Primary end point(s): Success of the procedure, defined as all of the following: • Completion of the procedure AND • No requirement for a rescue sedative medication AND • No requirement for more than the permitted bolus/infusion regimen;Timepoint(s) of evaluation of this end point: - After dosing of first 5 patients - Cohort 1, after dosing of at least 20 patients - Cohort 2, after dosing of at least 20 patients - Cohort 3, on an ongoing basis | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Target depth of sedation achieved (target depth of sedation on the UMSS will be predefined by investigator per patient based on the procedure and patient needs before the procedure.) • Target range of sedation achieved during 80% of procedure duration (target range of sedation on the UMSS will be predefined by investigator per patient based on the procedure and patient needs before the procedure.) • Percentage of time within target range of sedation during the procedure • Adequacy of sedation, assessed as NISS over time. • Time to target sedation level and start of procedure after first dose of IMP (minutes) • Time to fully alert (defined as the first of three consecutive UMSS scores of 0) after end of procedure and end of last dose of IMP [minutes] • Signs of re-sedation i.e. after reaching a UMSS of 0 after end of procedure, whether a UMSS score of >0 was seen in the time until discharge. • Time to fit for discharge after end of procedure and end of last dose of IMP [minutes] • Success of the procedure, excluding cases where the procedure could not be completed for non sedative reasons. Defined as all of the following: - Completion of the procedure AND - No requirement for a rescue sedative medication AND - No requirement for more than the permitted bolus or infusion regimen Secondary safety endpoints: • Treatment-emergent adverse events (TEAEs) after initiation of IMP • Vital signs (heart rate, blood pressure, body temperature and SpO2) • Need for any manual or mechanical ventilation, including mask ventilation without insertion of LMA/IGEL/ETT • Need for the reversal agent flumazenil, including reasons/indication for use • Emergence Delirium (paediatric anaesthesia emergence delirium scale) after end of procedure until fit for discharge.;Timepoint(s) of evaluation of this end point: After end of study. | — |
Countries
Denmark, United States
Contacts
Public ContactClinical Trial Information
PAION Deutschland GmbH
Outcome results
None listed