Comparison of AQUAVAN® Injection to DISOPRIVAN® Injectable Emulsion for Anesthesia During Coronary Artery Surgery
Condition: Ischemic Coronary Artery Disease; Coronary Artery Bypass Surgery
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): fospropofol; propofol
Intervention type(s): Drug; Drug
Intervention description(s): 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).; 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 intervention name(s): fospropofol disodium; LUSEDRA; E2083; GPI-15715; AQUAVAN; Disoprivan; propofol injectable emulsion
Intervention MeSH terms: Propofol; Fospropofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary Artery Bypass Surgery; AQUAVAN® Injection; DISOPRIVAN® Injectable Emulsion.; ischemic coronary artery disease