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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00209521
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 11, 2010
Sponsor:
Collaborator:
PPD
Information provided by:
Eisai Inc.

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date June 11, 2010
Study Start Date  ICMJE June 2002
Actual Primary Completion Date July 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2010)
Median time (minutes) to loss of consciousness from induction start (reported as median and range). [ Time Frame: Day 1 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • · To assess the sedative/hypnotic efficacy of AQUAVAN® Injection using DISOPRIVAN® Injectable Emulsion as a comparator.
  • · To evaluate the safety and tolerability of AQUAVAN® Injection.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2010)
  • Median time (minutes) to induction from start of infusion (reported as median and range). [ Time Frame: Day 1 ]
  • Time (minutes) to intubation from induction start (reported as median and range). [ Time Frame: Day 1 ]
  • Time (minutes) to extubation from end of infusion (reported as median and range). [ Time Frame: Day 1 ]
  • Time (minutes) to last suture from induction start (reported as median and range). [ Time Frame: Day 1 ]
  • Time (minutes) to full awareness from end of infusion (reported as median and range). [ Time Frame: Day 1 ]
  • Median time from End of Infusion to First Modified Ramsey Score of 3 (reported as median and range). [ Time Frame: Day 1 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • · To compare the intraoperative hemodynamic profiles of AQUAVAN® Injection to DISOPRIVAN® Injectable Emulsion.
  • · To compare the pharmacokinetic/pharmacodynamic (PK/PD) properties of propofol when derived from AQUAVAN® Injection to that derived from DISOPRIVAN® Injectable Emulsion.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of AQUAVAN® Injection to DISOPRIVAN® Injectable Emulsion for Anesthesia During Coronary Artery Surgery
Official Title  ICMJE Phase 2, Randomized Study of AQUAVAN® Injection In Elective Coronary Artery Surgery With Comparison to DISOPRIVAN® Injectable Emulsion
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.
Detailed Description

This Phase 2, open-label, single-center, randomized clinical trial was designed to examine the efficacy and tolerability of AQUAVAN® Injection (hereafter, referred to as AQUAVAN) when used to preoperatively sedate, induce, and maintain general anesthesia and to postoperatively sedate patients undergoing elective coronary artery surgery. Eligible patients were randomized to either AQUAVAN or DISOPRIVAN® Injectable Emulsion (hereafter, referred to as DISOPRIVAN) following screening and prior to their arrival in the surgical suite.

On the day of surgery, after the administration a 0.5 mg/kg bolus dose of lignocaine, preoperative sedation began using the target-controlled infusion (TCI) system to target desired sedation plasma concentrations of either AQUAVAN or DISOPRIVAN, depending on the randomization schedule.

The Bispectral (BIS) Index was used to guide study drug administration; target BIS ranges were 60 to 80 for sedation and 40 to 60 for the maintenance of anesthesia. Adequate sedative/hypnotic effect during surgical anesthesia was characterized by the portion of time within the target BIS Index range versus total surgical time. Following this, during postsurgical sedation, inadequate sedative/hypnotic effect was characterized by the number, duration, and magnitude of BIS scores outside of the target range versus total postsurgical sedation time. During postsurgical sedation, the Modified Ramsey Scale was used as an additional clinical tool to evaluate the state of sedation, with an attempt to maintain the score between 3 and 5.

The overall quality of induction, maintenance and ease of control of anesthesia, and quality of sedation before and during cardiopulmonary bypass (CPB), were each graded by the anesthesiologist.

Continuous monitoring of blood pressure and heart rate were used to assess the hemodynamic effect of study drug. Hypertension and hypotension were defined as excursions of >/= 20% from the baseline value.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ischemic Coronary Artery Disease
  • Coronary Artery Bypass Surgery
Intervention  ICMJE
  • Drug: fospropofol
    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).
    Other Names:
    • fospropofol disodium
    • LUSEDRA
    • E2083
    • GPI-15715
    • AQUAVAN
  • Drug: propofol
    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).
    Other Names:
    • Disoprivan
    • propofol injectable emulsion
Study Arms  ICMJE
  • Experimental: fospropofol
    Intervention: Drug: fospropofol
  • Active Comparator: propofol
    Intervention: Drug: propofol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2005)
16
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2003
Actual Primary Completion Date July 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00209521
Other Study ID Numbers  ICMJE 3000-0104
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James Vornov, MD, PhD, Guilford Pharmaceuticals, Inc.
Study Sponsor  ICMJE Eisai Inc.
Collaborators  ICMJE PPD
Investigators  ICMJE
Study Director: James Vornov, PhD,MD Eisai Inc.
PRS Account Eisai Inc.
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP