Procedural/Surgical anesthesia induction, administration and maintenance with propofol
combined with etomidate is commonly used in routine clinical practice in patient with
compromised cardiopulmonary status. However, there is no definitive trend or
understanding from the literature to discern which ratio of admixture is appropriate for
providing stable hemodynamics and minimizing side effects for procedural sedation in
gastrointestinal endoscopy procedures. Given the increasing volume for gastrointestinal
endoscopy, the increasingly older and greater chronic disease burden of the endoscopic
patient population, and the increased utilization of anesthesia for endoscopic procedures
this clinical trial aims to provide timely, meaningful and impactful guidance and
information for the safe conductance of anesthesia in this patient population.
The objectives are to compare the treatment arms, P2E7 and P7E2, in a randomized
controlled double-blind trial for anesthesia for endoscopic procedures. Comparison
between an admixture of Propofol/Etomidate 75%/25% versus 25%/75% being utilized as
principal anesthetic for endoscopic procedures at CUH endoscopy lab.
Propofol and etomidate can be mixed together in a syringe or similar container for up to
24 hours without adversely affecting appearance, pH, particle size and distribution, zeta
potential, observation under centrifugation and drug content and impurity demonstrating
the mixture to be physically and chemically compatible. Propofol and Etomidate are both
FDA approved for induction and maintenance of general anesthesia in adult patients.
Propofol and Etomidate in a wide ranging ratio of combinations in admixture have been
utilized for general anesthesia induction and maintenance both in regular standard of
care daily clinical practice and within a profound number of research trials including up
to a ratio of 80% etomidate and 20 % propofol by volume. Therefore the clinical practice
of etomidate and propofol in admixture for the induction and maintenance of general
anesthesia in adult patients is standard of care and well founded in the anesthesiology
literature. However, there are several important questions about which potential ratio of
both drugs provides the best combination of favorable cardiopulmonary effects while
having an acceptably low incidence of adverse effects. Thus, this current proposed trial
is intended to answer several important questions on that matter.
This trial also will have actual blinding of both patients and practitioners at time of
drug administration. Propofol is a white liquid and etomidate is a clear liquid. Thus,
past trials where either pure drug was given in sequence or at the same time by separate
syringes could not have had any blinding because of this obvious physical quality of the
medications. Therefore, only a trial involving an admixture of varying ratios of both
drugs could possibly hope to achieve actual blinding as is required for rigorous analysis
of results without introducing the bias that comes from a lack of true blinding of
patients and practitioners.
