RecruitingPhase 3

Propofol and Etomidate Admixtures Comparisons Trial (PEAC Trial)

United States200 participantsStarted 2022-09-19

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. 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)

What they're measuring

Time weighted average mean arterial pressure within treatment arm

Timeframe: Throughout entire study estimated to take 6 to 12 months to complete

Average within treatment arm vasopressor use by number of units

Timeframe: Throughout entire study estimated to take 6 to 12 months to complete

Average within treatment arm total minutes under 92% oxygen saturation

Timeframe: Throughout entire study estimated to take 6 to 12 months to complete

% of cases with any MAP below 50

Timeframe: Throughout entire study estimated to take 6 to 12 months to complete

% of cases with any MAP >60% below patient's immediate preoperative MAP

Timeframe: Throughout entire study estimated to take 6 to 12 months to complete

% of cases with any treatment for Post Operative Nausea and Vomiting

Timeframe: Throughout entire study estimated to take 6 to 12 months to complete

% of cases with any oxygen saturation event below 85% by pulse oximetry

Timeframe: Throughout entire study estimated to take 6 to 12 months to complete

Trial details

NCT IDNCT05358535

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Christopher Choi

2146486400 christopher.choi@utsouthwestern.edu

View on ClinicalTrials.gov More Anesthesia trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. 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)

What they're measuring

Time weighted average mean arterial pressure within treatment arm

Timeframe: Throughout entire study estimated to take 6 to 12 months to complete

Average within treatment arm vasopressor use by number of units

Timeframe: Throughout entire study estimated to take 6 to 12 months to complete

Average within treatment arm total minutes under 92% oxygen saturation

Timeframe: Throughout entire study estimated to take 6 to 12 months to complete

% of cases with any MAP below 50

Timeframe: Throughout entire study estimated to take 6 to 12 months to complete

% of cases with any MAP >60% below patient's immediate preoperative MAP

Timeframe: Throughout entire study estimated to take 6 to 12 months to complete

% of cases with any treatment for Post Operative Nausea and Vomiting

Timeframe: Throughout entire study estimated to take 6 to 12 months to complete

% of cases with any oxygen saturation event below 85% by pulse oximetry

Timeframe: Throughout entire study estimated to take 6 to 12 months to complete