Comparing two mixtures of propofol and etomidate for anesthesia during endoscopic procedures
Propofol and Etomidate Admixtures Comparisons Trial (PEAC Trial)
PHASE3 · University of Texas Southwestern Medical Center · NCT05358535
This study is testing two different mixtures of anesthesia to see which one works better for keeping patients stable and minimizing side effects during endoscopic procedures.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05358535 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the hemodynamic stability and adverse event profiles of two different admixtures of propofol and etomidate for anesthesia during endoscopic procedures. The study compares a 25% propofol and 75% etomidate mixture (P2E7) against a 75% propofol and 25% etomidate mixture (P7E2) in a randomized controlled double-blind design. It aims to provide insights into which admixture ratio is more effective in minimizing side effects and ensuring stable hemodynamics in patients with compromised cardiopulmonary status. The trial is conducted at the Clements University Hospital endoscopy lab, focusing on adult patients undergoing gastrointestinal endoscopy.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 and older who are scheduled for an endoscopic procedure at Clements University Hospital and have an ASA classification of 3 or above.
Not a fit: Patients with known allergies to the study drugs, those who refuse participation, or individuals with cognitive impairments that prevent informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer anesthesia practices for patients undergoing endoscopic procedures, particularly those with compromised health.
How similar studies have performed: While there is limited definitive literature on the optimal admixture ratios of propofol and etomidate, this study aims to fill a gap in understanding and may build on previous findings in anesthesia practices.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Dallas, Texas
- Clements University Hospital — Dallas, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Christopher Choi
- Email: christopher.choi@utsouthwestern.edu
- Phone: 2146486400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anesthesia, Propofol Adverse Reaction, Etomidate Adverse Reaction, Anesthesia Complication, Adverse Effect, Reaction, anesthesia, anesthesiology