Study to Assess Safety and Efficacy of AQUAVAN® Injection for Sedation During Cardiac Catheterization

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Inc.
• Collaborators: Covance; PPD
• Treatments: Fospropofol; Midazolam

Criteria

Inclusion Criteria:

1. Patient provided signed/dated Informed Consent and HIPAA authorization after receiving a full explanation of the extent and nature of the study.

2. Patient was at least 18 years of age at the time of screening (Prior to Amendment 2 [dated 04 February 2005], the patient was required to be between 18 and 65 years of age, inclusive. Three subjects were randomized under this earlier inclusion criteria).

3. If female, patient was surgically sterile, postmenopausal or not pregnant or lactating and had been using an acceptable method of birth control for at least 1 month prior to dosing, with a negative urine pregnancy test result at Screening and Predosing Periods.

4. Patient met American Society of Anesthesiologists (ASA)13, 14 Physical Status Classification System level I to III; and

5. Patient was an inpatient or outpatient scheduled to undergo a single PC procedure.

Exclusion Criteria:

1. Patient had history of allergic reaction or hypersensitivity to any anesthetic agent, narcotic, or benzodiazepine.

2. Patient did not meet nils per os (NPO) status per ASA Guideline or institution's guideline.

3. Patient had a condition(s) that, in the opinion of the Investigator, could interfere with appropriate airway management.

4. Patient had participated in an investigational drug study within 1 month prior to study start.

5. Patient had history of mental or visual impairment that would not permit successful measurement of cognitive evaluations.

6. Patient was unwilling to adhere to pre- and postprocedural instructions; or

7. Patient for whom the use of fentanyl or midazolam was contraindicated.