Propofol and Etomidate Admixtures Comparisons Trial (PEAC Trial)

STU-TBD

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).

2022-09-19

2024-06-01

2024-12-01

Recruiting

Early phase I

200

Inclusion Criteria: 1. Adult patients (age ≥18 years old) 2. Having endoscopic procedure at CUH with anesthesia 3. ASA 3 or above 4. Ejection Fraction test result available Exclusion Criteria: 1. Known allergies or adverse reactions to study drugs or study drug components or preservatives 2. Patient refusal 3. Clinician refusal 4. Documented cognitive impairments precluding subject ability to consent for themselves unless a surrogate documented legally acceptable decision maker consents for patient participation 5. Prisoner or incarcerated or patients held by law enforcement officials in custody 6. Pregnancy or patient refusal for pregnancy testing or screening (standard UTSW policy and protocol requires pregnancy testing for appropriate patients prior to anesthesia)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This a prospective double blind randomized controlled clinical trial. 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 endoscopy lab.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "Blinding plan: Either the investigational drug service with the CUH central pharmacy will prepare the admixture syringes or a separate anesthesia staff not involved in subject's case will prepare admixture syringes thus preventing any case personnel involved with subject's case or subject from knowing which admixture is present within syringes for subject's case.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2023-07-28