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General Anesthetic

Propofol-Etomidate Admixtures for Anesthesia (PEAC Trial)

Phase 3
Recruiting
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ASA 3 or above
Be older than 18 years old
Must not have
Documented cognitive impairments precluding subject ability to consent for themselves unless a surrogate documented legally acceptable decision maker consents for patient participation
Clinician refusal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout entire study estimated to take 6 to 12 months to complete
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the effects of two different ratios of propofol and etomidate on patients undergoing endoscopic procedures.

Who is the study for?
This trial is for adults (18+) who are classified as ASA 3 or above, meaning they have severe systemic disease. They must be scheduled for an endoscopic procedure with anesthesia at CUH and have a recent Ejection Fraction test result. Excluded are pregnant individuals, prisoners, those unable to consent, and anyone allergic to the study drugs.
What is being tested?
The PEAC Trial is testing two mixtures of anesthesia drugs during endoscopy: one group receives propofol and etomidate in a 25%/75% ratio (P2E7), while another gets a 75%/25% ratio (P7E2). The goal is to compare blood pressure stability and side effects between these two ratios.
What are the potential side effects?
Potential side effects may include typical reactions to anesthesia such as nausea, dizziness, or respiratory issues. Since both propofol and etomidate can cause adverse reactions individually, their combination might also lead to unique side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a serious health condition but I'm not at immediate risk of death.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a cognitive condition that requires someone else to make decisions for me.
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My doctor has advised against me joining this trial.
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I have chosen not to participate in certain treatments or procedures.
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I have no allergies to the study drugs or their components.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout entire study estimated to take 6 to 12 months to complete
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout entire study estimated to take 6 to 12 months to complete for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
% of cases with any MAP >60% below patient's immediate preoperative MAP
% of cases with any MAP below 50
% of cases with any oxygen saturation event below 85% by pulse oximetry
+9 more
Secondary study objectives
Average time from dressing complete to modified Aldrete score >8
Average time in immediate recovery area before discharge to next phase of care
Average within treatment arm total dose (mL) of admixture administered
+17 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2)Experimental Treatment1 Intervention
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.
Group II: Admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7)Experimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,083 Previous Clinical Trials
1,058,489 Total Patients Enrolled
Kapil AnandStudy DirectorUniversity of Texas

Media Library

Admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7) (General Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05358535 — Phase 3
Anesthesia Research Study Groups: Admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2), Admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7)
Anesthesia Clinical Trial 2023: Admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7) Highlights & Side Effects. Trial Name: NCT05358535 — Phase 3
Admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7) (General Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05358535 — Phase 3
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