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Ischemic Coronary Artery DiseasePhase 2NCT00209521

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

A Phase 2 study testing fospropofol and propofol in people with Ischemic Coronary Artery Disease and Coronary Artery Bypass Surgery, run by Eisai Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 70 years
What is being tested?
fospropofol and propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
No sites listed yet
Study dates
Jun 2002to Jul 2003
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.
  • 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.
  • 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.
  • Patient had any history of adverse reaction to any opiate or anesthetic agent.
  • Patient, if male, did not agree to use an effective method of birth control between the time of screening and end of study.

About this study

Official title: Phase 2, Randomized Study of AQUAVAN® Injection In Elective Coronary Artery Surgery With Comparison to DISOPRIVAN® Injectable Emulsion

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.

Read the 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.

Being tested
fospropofol, propofol
Keywords
Coronary Artery Bypass Surgery, AQUAVAN® Injection, DISOPRIVAN® Injectable Emulsion., ischemic coronary artery disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fospropofolDrug

    Also called fospropofol disodium, LUSEDRA, E2083, GPI-15715

    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).

  • propofolDrug

    Also called Disoprivan, propofol injectable emulsion

    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).

Study groups in NCT00209521
Study groupRoleWhat they receive
fospropofolExperimentalNot described
Receives: Drug: fospropofol
propofolActive comparatorNot described
Receives: Drug: propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 1

Secondary outcomes (6)

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

    Measured: Day 1

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

    Measured: Day 1

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

    Measured: Day 1

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

    Measured: Day 1

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

    Measured: Day 1

  6. Median time from End of Infusion to First Modified Ramsey Score of 3 (reported as median and range).

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2005 (estimated)
  2. Study startJun 2002
  3. Primary completionJul 2003
  4. Study completionJul 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00209521
Sponsor's protocol ID
3000-0104
Status last verified
Jun 2010
First submitted
13 Sep 2005
Last updated
11 Jun 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fospropofol and propofol in people with Ischemic Coronary Artery Disease and Coronary Artery Bypass Surgery, run by Eisai Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median time (minutes) to loss of consciousness from induction start (reported as median and range). (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00209521.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2010.

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