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

NCT00209521 | Completed Phase 2

• 1 other identifier: 3000-0104
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ischemic Coronary Artery Disease; Coronary Artery Bypass Surgery

Keywords

Coronary Artery Bypass Surgery; AQUAVAN® Injection; DISOPRIVAN® Injectable Emulsion.; ischemic coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Median time (minutes) to loss of consciousness from induction start (reported as median and range).

  Day 1

Secondary Outcomes (6)

• Median time (minutes) to induction from start of infusion (reported as median and range).

  Day 1

• Time (minutes) to intubation from induction start (reported as median and range).

  Day 1

• Time (minutes) to extubation from end of infusion (reported as median and range).

  Day 1

• Time (minutes) to last suture from induction start (reported as median and range).

  Day 1

• Time (minutes) to full awareness from end of infusion (reported as median and range).

  Day 1

Study Arms (2)

fospropofol

EXPERIMENTAL

Drug: fospropofol

propofol

ACTIVE COMPARATOR

Drug: propofol

Interventions

fospropofol DRUG

Using a Target Controlled Infusion (TCI) system, the target plasma concentrations of propofol to be administered from AQUAVAN were 0.7 μg/mL (sedation) and 2.5 μg/mL (maintain anesthesia).

Also known as: fospropofol disodium, LUSEDRA, E2083, GPI-15715, AQUAVAN

fospropofol

propofol DRUG

Using a Target Controlled Infusion (TCI) system, the target plasma concentrations of propofol to be administered from Disoprivan were 1.0 μg/mL (sedation) and 3.0 μg/mL (maintain anesthesia).

Also known as: Disoprivan, propofol injectable emulsion

propofol

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were between the ages of 21 and 70 years, inclusive.
• Patients were scheduled for first-time elective coronary artery bypass graft surgery, with 1 to 4 grafts planned.
• Patients had an American Society of Anesthesiologists (ASA) Physical Classification System status of II or III.
• Patients had a "good" left ventricular function as defined by a cardiac ejection fraction \>=50% measured by cardiac catheterization or other quantitative technique.
• 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.
• Patients, if female, were surgically sterile or postmenopausal.

You may not qualify if:

• Patient had prior coronary bypass grafting or other cardiac surgery.
• Patient had uncontrolled hypertension (diastolic \>110 mm Hg) or required additional intervention while hospitalized prior to surgery to control blood pressure.
• Patient had a medical history of renal disease or creatinine \>1.4 mg/dL.
• Patient had known hemodynamically significant valvular abnormalities, except Grade 1 tricuspid or mitral insufficiency.
• Patient had severe obesity, defined as a body mass index (BMI) \>35.
• Patient failed the Allen's Test to confirm the patency of the ulnar artery.
• Patient had severe or uncontrolled systemic illness (e.g., pulmonary disease, cancer, endocrine abnormalities).
• Patient had insulin-dependent diabetes.
• Patient had a history of stroke or current neurological disease (e.g., dementia, neuropathy), as determined by the Investigator.
• Patient had anticipated difficulties with intubation, in the judgment of the Investigator.
• Patient had a history of alcohol abuse, as determined by the Investigator;
• Patient had participated in an investigational drug study within 1 month prior to study start.
• Patient had donated \>300 mL of blood within 1 month prior to study start.
• Patient had a positive medical history for drug abuse.
• Patient had a known infection with human immunodeficiency virus (HIV), Hepatitis B, and/or Hepatitis C.

Sponsors & Collaborators

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

MeSH Terms

Interventions

fospropofol; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• James Vornov, PhD,MD

  Eisai Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: June 1, 2002
• Primary Completion: July 1, 2003
• Study Completion: July 1, 2003
• Last Updated: June 11, 2010

Record last verified: 2010-06