Study to Assess Safety and Efficacy of AQUAVAN® Injection for Sedation During Cardiac Catheterization
Status:
Completed
Trial end date:
2005-03-01
Target enrollment:
Participant gender:
Summary
The anticipation of pain and discomfort, a diagnosis, and other intrinsic unknowns make
patients anxious both prior to and during a procedure. Therefore, the main goal of sedation
with analgesia used during various diagnostic, therapeutic, or surgical procedures is to
relieve this anxiety, discomfort, and pain, which are all interrelated. The optimal level of
sedation for any given patient is one that allows the patient to tolerate the procedure and
provides an appropriate safety margin. This was a study designed to examine the safety and
efficacy of AQUAVAN® Injection versus a commonly used approved sedative drug, midazolam HCl
following pretreatment with fentanyl citrate injection (for pain relief) in producing
sedation in patients undergoing single cardiac catheterization procedures.