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

NCT00209547 | Completed Phase 3

• 1 other identifier: 3000-0411
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Angioplasty; Coronary Catheterization

Keywords

AQUAVAN® Injection; Midazolam; Angioplasty; Coronary catheterization

Outcome Measures

Primary Outcomes (1)

• Demonstrate that AQUAVAN was effective in providing adequate sedation in patients undergoing percutaneous coronary (PC) procedures.

Secondary Outcomes (1)

• Treatment-emergent adverse events, Sedation-related adverse events, and airway Assistance.

Interventions

fospropofol disodium DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient provided signed/dated Informed Consent and HIPAA authorization after receiving a full explanation of the extent and nature of the study.
• 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.
• Patient met American Society of Anesthesiologists (ASA)13, 14 Physical Status Classification System level I to III; and
• Patient was an inpatient or outpatient scheduled to undergo a single PC procedure.

You may not qualify if:

• Patient had history of allergic reaction or hypersensitivity to any anesthetic agent, narcotic, or benzodiazepine.
• Patient did not meet nils per os (NPO) status per ASA Guideline or institution's guideline.
• Patient had a condition(s) that, in the opinion of the Investigator, could interfere with appropriate airway management.
• Patient had participated in an investigational drug study within 1 month prior to study start.
• Patient had history of mental or visual impairment that would not permit successful measurement of cognitive evaluations.
• Patient was unwilling to adhere to pre- and postprocedural instructions; or
• Patient for whom the use of fentanyl or midazolam was contraindicated.

Sponsors & Collaborators

• Eisai Inc.: lead
• PPD Development, LP: collaborator
• Covance: collaborator

MeSH Terms

Interventions

fospropofol

Study Officials

• James Jones, MD,PharmD

  Eisai Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: February 1, 2004
• Study Completion: March 1, 2005
• Last Updated: November 7, 2008

Record last verified: 2008-11