RecruitingPhase 3NCT05358535

Propofol and Etomidate Admixtures Comparisons Trial (PEAC Trial)


Sponsor

University of Texas Southwestern Medical Center

Enrollment

200 participants

Start Date

Sep 19, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the hemodynamics and adverse event profile in comparison between two treatment arms, one using an admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7), and one using an admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2), for anesthesia during endoscopic procedures at the Clements University Hospital (CUH) endoscopy lab (Endo).


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Adult patients (age ≥18 years old)
  • Having endoscopic procedure at CUH with anesthesia
  • ASA 3 or above
  • Ejection Fraction test result available

Exclusion Criteria6

  • Known allergies or adverse reactions to study drugs or study drug components or preservatives
  • Patient refusal
  • Clinician refusal
  • Documented cognitive impairments precluding subject ability to consent for themselves unless a surrogate documented legally acceptable decision maker consents for patient participation
  • Prisoner or incarcerated or patients held by law enforcement officials in custody
  • Pregnancy or patient refusal for pregnancy testing or screening (standard UTSW policy and protocol requires pregnancy testing for appropriate patients prior to anesthesia)

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Interventions

DRUGAdmixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2)

The purpose of this study is to evaluate the hemodynamics and adverse event profile in comparison between two treatment arms, one using an admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7), and one using an admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2), for anesthesia during endoscopic procedures at the Clements University Hospital (CUH) endoscopy lab (Endo). 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.

DRUGAdmixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7)

The purpose of this study is to evaluate the hemodynamics and adverse event profile in comparison between two treatment arms, one using an admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7), and one using an admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2), for anesthesia during endoscopic procedures at the Clements University Hospital (CUH) endoscopy lab (Endo). 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.


Locations(1)

Clements University Hospital

Dallas, Texas, United States

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NCT05358535


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