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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout entire study estimated to take 6 to 12 months to complete

Awards & highlights

PEAC 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.Check my eligibility

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.See study design

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.

PEAC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a serious health condition but I'm not at immediate risk of death.

PEAC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout entire study estimated to take 6 to 12 months to complete

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

% 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 outcome measures

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

PEAC 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,535 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many total subjects are being used in this clinical trial?

"That is correct, the online information on clinicaltrials.gov states that this particular trial is still recruiting patients. The posting date was September 19th, 2022 and the most recent update was on October 31st, of the same year. They are looking for a total of 200 individuals from 1 locations."

Answered by AI

What medical goal does this experiment hope to achieve?

"This study will last 6 to 12 months, during which time the primary outcome (reduction in oxygen saturation events below 85% by pulse oximetry) will be monitored. Secondary outcomes include airway adjunct usage (oral airway, nasal airway, need for intermittent mask ventilation), number of classic MACE events in the 30 days after starting on day of drug administration, and average of endoscopists' assessment of quality of anesthesia during case: Poor, Below Average, Average, Above Average, Excellent (0,1,2,3 from all endoscopy staff then average for each treatment arm."

Answered by AI

Is the P7E2 mixture of propofol and etomidate safe for human use?

"Admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2) is considered safe according to our team's estimation. This is backed by multiple rounds of data from Phase 3 trials, which support both efficacy and safety."

Answered by AI

Are there any available slots for individuals in this particular trial?

"The online database clinicaltrials.gov has this study listed as active and currently looking for participants. The trial was originally put up on September 19th, 2022 with the most recent update occurring on October 31st, 2022."

Answered by AI