Propofol-Etomidate Admixtures for Anesthesia

(PEAC Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Allergies, Cognitive impairments, Pregnancy, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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. ^{1 2 3 4 5}

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. ^{1 3 5 6 7}

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. ^{1 2 3 8 9}

Research Team

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.

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.

Trial 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) (General Anesthetic)
• Admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2) (General Anesthetic)

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.

Participant Groups

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+

Daniel K. Podolsky

University of Texas Southwestern Medical Center

Chief Executive Officer since 2008

MD from Harvard Medical School

Robert L. Bass

University of Texas Southwestern Medical Center

Chief Medical Officer since 2019

MD from University of Texas Southwestern Medical School

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.

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 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 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]

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]

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]

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]

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]

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]

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]

References

1. Turkey pubmed.ncbi.nlm.nih.gov

Clinical Analysis of Propofol, Etomidate and an Admixture of Etomidate and Propofol for Induction of General Anaesthesia. [2022]

2. Greece pubmed.ncbi.nlm.nih.gov

Safety and efficacy of etomidate and propofol anesthesia in elderly patients undergoing gastroscopy: A double-blind randomized clinical study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Etomidate Sedation for Advanced Endoscopic Procedures. [2020]

4. France pubmed.ncbi.nlm.nih.gov

[Propofol and etomidate: a comparative study in emergency anesthesia in ASA I and II patients]. [2013]

5. India 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of etomidate versus propofol for procedural sedation in the emergency department. [2022]

7. United States 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. [2022]

8. India pubmed.ncbi.nlm.nih.gov

A clinical comparison of etomidate-lipuro, propofol and admixture at induction. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Etomidate and propylene glycol activate nociceptive TRP ion channels. [2019]