Propofol-Etomidate Admixtures for Anesthesia

(PEAC Trial)

Overseen By Kapil Anand

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Allergies, Cognitive impairments, Pregnancy, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 to 12 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two different mixtures of propofol and etomidate, drugs used for anesthesia during procedures like endoscopies. The researchers aim to compare how these mixtures affect heart function and any side effects they might cause. Participants will receive one of two mixtures: one with more propofol or one with more etomidate. Suitable candidates for this trial are adults undergoing an endoscopic procedure with anesthesia at Clements University Hospital. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of safer anesthesia options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mixing propofol and etomidate is generally safe. One study found that using these drugs together for procedures like gastroscopy helps maintain stable blood pressure and heart rate. This stability reduces stress on the heart and blood circulation.

Patients who received both propofol and etomidate experienced fewer blood circulation problems than those who received only propofol, though recovery might take slightly longer. No major safety issues have been reported with this drug combination, which is reassuring.

Since this trial is in a later stage, earlier tests have already demonstrated the treatment's safety. Serious side effects are unlikely, but careful monitoring remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the propofol-etomidate admixtures because they could offer a more balanced approach to anesthesia during endoscopic procedures. Unlike standard anesthesia options that often rely solely on propofol or etomidate, these admixtures combine both drugs in different ratios (25% propofol/75% etomidate and 75% propofol/25% etomidate), potentially improving hemodynamic stability and reducing adverse events. This dual-drug approach aims to harness the benefits of both agents—propofol's rapid onset and etomidate's cardiovascular stability—while minimizing their individual drawbacks. By exploring these combinations, researchers hope to find a more effective and safer way to manage anesthesia, which is why these trials are generating excitement.

What evidence suggests that this trial's treatments could be effective for anesthesia during endoscopic procedures?

This trial compares two different admixtures of propofol and etomidate for anesthesia during endoscopic procedures. Research has shown that combining propofol and etomidate can stabilize blood flow during procedures like endoscopies. Participants in one arm of the trial will receive an admixture with 25% propofol and 75% etomidate (P2E7), which may better control heart rate and blood pressure while allowing for quicker recovery after surgery. Participants in the other arm will receive a mix with 75% propofol and 25% etomidate (P7E2), which offers similar stability with fewer side effects. Both mixtures aim to provide effective anesthesia with minimal negative effects, making them promising options for safe sedation. ^{1 2 4 6 7}

Who Is on the Research Team?

Kapil Anand

Principal Investigator

University of Texas

Are You a Good Fit for This Trial?

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

Ejection Fraction test result available

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

I am scheduled for an endoscopic procedure with anesthesia at CUH.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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 Overview 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.

How Is the Trial Designed?

Group I: Admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2) Experimental Treatment 1 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 Treatment 1 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.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

In a study of 271 adults undergoing deep sedation, the frequency of airway and respiratory adverse events requiring intervention was similar across groups receiving propofol alone and two different mixtures of propofol and ketamine (1:1 and 4:1).

No serious adverse events occurred in any group, indicating that all sedation methods were safe, although the 1:1 ketofol mixture was associated with higher recovery agitation compared to the other groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, double-blinded, clinical trial of propofol, 1:1 propofol/ketamine, and 4:1 propofol/ketamine for deep procedural sedation in the emergency department. Miner, JR., Moore, JC., Austad, EJ., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Etomidate Sedation for Advanced Endoscopic Procedures. Han, SJ., Lee, TH., Yang, JK., et al.[2020]

The 1:1 admixture of etomidate-lipuro and propofol resulted in the fastest induction time (BIS 40 time) compared to either agent alone, indicating it may provide a more efficient onset of anesthesia.

Patients receiving the admixture experienced significantly fewer hemodynamic changes, myoclonus, and injection pain compared to those receiving propofol or etomidate-lipuro alone, suggesting it is a safer option for induction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical comparison of etomidate-lipuro, propofol and admixture at induction. Saricaoglu, F., Uzun, S., Arun, O., et al.[2021]

In a study of 214 patients undergoing procedural sedation in the emergency department, both etomidate and propofol were found to be equally safe, with no clinically significant complications reported.

However, etomidate was associated with a lower procedural success rate (88.6%) compared to propofol (97.2%) and caused myoclonus in 20% of patients, indicating potential drawbacks despite its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of etomidate versus propofol for procedural sedation in the emergency department. Miner, JR., Danahy, M., Moch, A., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 112 patients receiving procedural sedation and analgesia, the combination of etofen (etomidate and fentanyl) resulted in significantly lower rates of respiratory adverse events compared to ketofol (ketamine and propofol), with a higher need for interventions in the ketofol group.

Etofen also demonstrated a better hemodynamic profile, making it a safer option for adult patients undergoing procedures requiring sedation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of ketamine/propofol (ketofol) and etomidate/fentanyl (etofen) combinations for procedural sedation and analgesia in the emergency department: An observational study. Sanri, E., Karacabey, S., Akoglu, H., et al.[2022]

Etomidate and its solubilizer propylene glycol activate pain-related ion channels (TRPA1 and TRPV1) in sensory neurons, leading to significant burning pain upon injection, as demonstrated in both cell line studies and a human pain model.

The study found that the painful effects of etomidate injections are specifically due to the activation of these ion channels, rather than being a result of high osmolarity, suggesting that modifying the formulation could reduce injection pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Etomidate and propylene glycol activate nociceptive TRP ion channels. Niedermirtl, F., Eberhardt, M., Namer, B., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 involving 50 patients (39 ASA I and 11 ASA II), propofol was found to be effective for emergency anesthesia, showing a decrease in diastolic blood pressure without harmful effects on patients' stability.

Propofol also allowed for a significantly shorter recovery time for memory compared to etomidate, making it the preferred choice in stable patients during emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Propofol and etomidate: a comparative study in emergency anesthesia in ASA I and II patients]. Izard, P., Coustets, B., Olivier, M., et al.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05358535

Propofol and Etomidate Admixtures Comparisons 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11199870/

a study on the etomidate/propofol mixture ratio - PubMed Central The use of a mixture of 10 mL etomidate and 10 mL propofol (at a 1:1 ratio) combined with dezocine for painless gastroscopy demonstrates hemodynamic stability.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7647540/

Clinical observation of the combined use of propofol and ... Our data indicate that the combination of 10 ml 1.0% propofol and 5 ml 0.2% etomidate for painless gastroscopy reduces adverse reactions while not affecting ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0104001415000421

A comparative study between propofol and etomidate in ... This study concludes that etomidate is a better agent for induction than propofol in view of hemodynamic stability and less pain on injection. Resumo ...

5. pdfs.semanticscholar.org pdfs.semanticscholar.org/8669/3d97d1d8b84ad3c0ba5b2f609667b1435b6e.pdf

Clinical efficacy of a combination of propofol and etomidate ... Results: In group A, the mean arterial pressure (MAP) and heart rate (HR) were improved; anesthesia induction time and wake-up time after surgery were shorter, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6531275/

Safety and efficacy of combined use of propofol ... The combination of propofol and etomidate might increase recovery time vs that associated with propofol, but it had fewer side effects on circulation and ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28284883/

Etomidate Versus Propofol Sedation for Complex Upper ... The objective of this study was to compare safety and efficacy profiles of etomidate and propofol for endoscopic sedation. Methods: A total of 128 patients ...