Arthroscopy Clinical Trial
Official title:
A Phase III, Randomized, Open-label Study to Assess the Safety and Efficacy of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Minor Surgical Procedures
The purpose of this study is to determine the safety, tolerability, and efficacy of AQUAVAN® Injection when used for mild-to-moderate sedation in patients undergoing minor surgical procedures.
Randomized, open label, multi-center,midazolam adaptive dose ranging study, in which several
dose levels of AQUAVAN® Injection and fentanyl citrate injection will be investigated to
produce a desired sedation level in patients undergoing minor surgical and/or therapeutic
procedures. A desired sedative dose/dose range and dosing paradigm will be identified based
on pre-set criteria using the Modified Observer's Assessment of Alertness/Sedation (OAA/S).
The desired sedative dose/dose range and dosing paradigm of AQUAVAN® Injection is defined as
one that consistently provides mild to moderate sedation (Modified OAA/S between 2 and 4
inclusive) in majority of patients who are pre-medicated with fentanyl citrate injection.
Midazolam is the most widely used i.v. agent for minimal-to-moderate sedation. The dose
range of midazolam to induce minimal to moderate sedation was based on standard clinical
practice.
[new paragraph] All patients were pre-medicated with fentanyl citrate as an analgesic.
The outpatient setting has become increasingly popular for various types of medical
procedures requiring sedation. In outpatient minor surgical procedures, sedation agents are
used to provide mild-to-moderate sedation and are used with other medicines for pain
management. Surgeons have searched for alternative treatments to use in the outpatient
setting that would provide a faster recovery time with minimal post-procedure amnesia. This
injection is used following pretreatment with fentanyl citrate for pain management.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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