200 Participants Needed

Propofol-Etomidate Admixtures for Anesthesia

(PEAC Trial)

CC
JH
KA
Overseen ByKapil Anand
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this 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 (CUH) endoscopy lab (Endo).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug admixture of propofol and etomidate for anesthesia?

Research shows that combining propofol and etomidate for anesthesia can be safe and effective, especially in elderly patients undergoing procedures like gastroscopy. This combination improves stability of vital signs, causes fewer breathing issues, and allows for a quicker recovery, leading to high satisfaction levels among patients and medical staff.12345

Is the admixture of propofol and etomidate safe for use in humans?

A study compared the safety of using a 50% admixture of propofol and etomidate for general anesthesia, suggesting it is generally safe for human use, but specific safety data for the 25%/75% or 75%/25% ratios is not provided.13567

How is the propofol-etomidate admixture drug different from other anesthesia drugs?

The propofol-etomidate admixture is unique because it combines two drugs in specific ratios (25%/75% and 75%/25%) to balance the benefits of both: propofol's rapid onset and etomidate's cardiovascular stability, potentially reducing side effects like respiratory depression and providing a smoother recovery compared to using each drug alone.12389

Research Team

KA

Kapil Anand

Principal Investigator

University of Texas

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.
Ejection Fraction test result available
I have a serious health condition but I'm not at immediate risk of death.
See 1 more

Exclusion Criteria

I have a cognitive condition that requires someone else to make decisions for me.
Prisoner or incarcerated or patients held by law enforcement officials in custody
My doctor has advised against me joining this trial.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive anesthesia using an admixture of propofol and etomidate in two different ratios (P2E7 and P7E2) during endoscopic procedures

6 to 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of hemodynamics and adverse events

4 weeks

Treatment Details

Interventions

  • Admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7)
  • Admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2)
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Findings from Research

The combination of propofol and etomidate (group PE) significantly reduced the incidence of myoclonus and pain upon injection compared to propofol alone (group P), indicating a safer profile for induction of anesthesia.
Induction with the propofol-etomidate mixture also resulted in less hemodynamic instability compared to propofol alone, suggesting it may be a more effective option for maintaining stable blood pressure during anesthesia induction.
Clinical Analysis of Propofol, Etomidate and an Admixture of Etomidate and Propofol for Induction of General Anaesthesia.Rathore, VS., Singh, S., Taank, P., et al.[2022]
In a study of 200 elderly patients undergoing gastroscopy, the combination of propofol and etomidate provided safe and effective anesthesia, improving hemodynamic stability and minimizing respiratory depression compared to using etomidate alone.
While recovery and discharge times were longer with etomidate alone, the combined regimen did not significantly affect patient satisfaction or anesthesia evaluation, indicating it is a viable option for elderly patients.
Safety and efficacy of etomidate and propofol anesthesia in elderly patients undergoing gastroscopy: A double-blind randomized clinical study.Meng, QT., Cao, C., Liu, HM., et al.[2022]
In a study of 186 patients undergoing advanced endoscopic procedures, etomidate sedation (BES) was found to have a lower incidence of cardiopulmonary adverse events compared to propofol sedation (BPS), with a significant reduction in overall adverse events (27.7% vs. 14.1%).
While BES did not achieve noninferiority in patient satisfaction compared to BPS, it demonstrated better safety outcomes, making it a potentially safer alternative for sedation during endoscopic procedures.
Etomidate Sedation for Advanced Endoscopic Procedures.Han, SJ., Lee, TH., Yang, JK., et al.[2020]

References

Clinical Analysis of Propofol, Etomidate and an Admixture of Etomidate and Propofol for Induction of General Anaesthesia. [2022]
Safety and efficacy of etomidate and propofol anesthesia in elderly patients undergoing gastroscopy: A double-blind randomized clinical study. [2022]
Etomidate Sedation for Advanced Endoscopic Procedures. [2020]
[Propofol and etomidate: a comparative study in emergency anesthesia in ASA I and II patients]. [2013]
Comparison of ketamine/propofol (ketofol) and etomidate/fentanyl (etofen) combinations for procedural sedation and analgesia in the emergency department: An observational study. [2022]
Randomized clinical trial of etomidate versus propofol for procedural sedation in the emergency department. [2022]
Randomized, double-blinded, clinical trial of propofol, 1:1 propofol/ketamine, and 4:1 propofol/ketamine for deep procedural sedation in the emergency department. [2022]
A clinical comparison of etomidate-lipuro, propofol and admixture at induction. [2021]
Etomidate and propylene glycol activate nociceptive TRP ion channels. [2019]