Comparison of AQUAVAN® Injection to DISOPRIVAN® Injectable Emulsion for Anesthesia During Coronary Artery Surgery

• Status: Completed
• Trial end date: 2003-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an exploratory clinical trial designed to examine the efficacy, safety and tolerability of fospropofol (AQUAVAN) Injection compared to propofol (DISOPRIVAN) Injectable Emulsion when used to preoperatively sedate, induce, and maintain general anesthesia and to postoperatively sedate patients undergoing elective coronary artery surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Inc.
• Collaborator: PPD
• Treatments: Anesthetics; Fospropofol; Propofol

Criteria

Inclusion Criteria:

1. Patients were between the ages of 21 and 70 years, inclusive.

2. Patients were scheduled for first-time elective coronary artery bypass graft surgery, with 1 to 4 grafts planned.

3. Patients had an American Society of Anesthesiologists (ASA) Physical Classification System status of II or III.

4. Patients had a "good" left ventricular function as defined by a cardiac ejection fraction >=50% measured by cardiac catheterization or other quantitative technique.

5. Patients provided written Informed Consent after receiving a full explanation of the extent and nature of the study and were willing to comply with the study procedures.

6. Patients, if female, were surgically sterile or postmenopausal.

Exclusion Criteria:

1. Patient had prior coronary bypass grafting or other cardiac surgery.

2. Patient had uncontrolled hypertension (diastolic >110 mm Hg) or required additional intervention while hospitalized prior to surgery to control blood pressure.

3. Patient had a medical history of renal disease or creatinine >1.4 mg/dL.

4. Patient had known hemodynamically significant valvular abnormalities, except Grade 1 tricuspid or mitral insufficiency.

5. Patient had severe obesity, defined as a body mass index (BMI) >35.

6. Patient failed the Allen's Test to confirm the patency of the ulnar artery.

7. Patient had severe or uncontrolled systemic illness (e.g., pulmonary disease, cancer, endocrine abnormalities).

8. Patient had insulin-dependent diabetes.

9. Patient had a history of stroke or current neurological disease (e.g., dementia, neuropathy), as determined by the Investigator.

10. Patient had anticipated difficulties with intubation, in the judgment of the Investigator.

11. Patient had a history of alcohol abuse, as determined by the Investigator;

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

13. Patient had donated >300 mL of blood within 1 month prior to study start.

14. Patient had a positive medical history for drug abuse.

15. Patient had a known infection with human immunodeficiency virus (HIV), Hepatitis B, and/or Hepatitis C.

16. Patient had any history of anxiety or psychiatric illness or was currently using antidepressants, monoamine oxidase (MAO) inhibitors, anti-anxiety medications or other drugs with central nervous system (CNS) effects prior to their preoperative hospital stay.

17. Patient had uncorrected visual problems, including cataracts, glaucoma, or any significant abnormalities found on fundoscopic examination that would interfere with visual assessment of drug safety.

18. Patient had any history of adverse reaction to any opiate or anesthetic agent.

19. Patient, if male, did not agree to use an effective method of birth control between the time of screening and end of study.