Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05358535

Propofol and Etomidate Admixtures Comparisons Trial (PEAC 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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Anesthesia Anesthesia Complication Anesthesia; Adverse Effect Anesthesia; Reaction Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Etomidate Adverse Reaction Propofol Adverse Reaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clements University Hospital

Dallas, Texas, 75390, United States

Location status: Recruiting

Location contact

Joseph M Hendrix, MD

CONTACT

8172667987

About this study

Procedural/Surgical anesthesia induction, administration and maintenance with propofol combined with etomidate is commonly used in routine clinical practice in patient with compromised cardiopulmonary status. However, there is no definitive trend or understanding from the literature to discern which ratio of admixture is appropriate for providing stable hemodynamics and minimizing side effects for procedural sedation in gastrointestinal endoscopy procedures. Given the increasing volume for gastrointestinal endoscopy, the increasingly older and greater chronic disease burden of the endoscopic patient population, and the increased utilization of anesthesia for endoscopic procedures this clinical trial aims to provide timely, meaningful and impactful guidance and information for the safe conductance of anesthesia in this patient population.

The objectives are to compare the treatment arms, P2E7 and P7E2, in a randomized controlled double-blind trial for anesthesia for endoscopic procedures. Comparison between an admixture of Propofol/Etomidate 75%/25% versus 25%/75% being utilized as principal anesthetic for endoscopic procedures at CUH endoscopy lab.

Propofol and etomidate can be mixed together in a syringe or similar container for up to 24 hours without adversely affecting appearance, pH, particle size and distribution, zeta potential, observation under centrifugation and drug content and impurity demonstrating the mixture to be physically and chemically compatible. Propofol and Etomidate are both FDA approved for induction and maintenance of general anesthesia in adult patients. Propofol and Etomidate in a wide ranging ratio of combinations in admixture have been utilized for general anesthesia induction and maintenance both in regular standard of care daily clinical practice and within a profound number of research trials including up to a ratio of 80% etomidate and 20 % propofol by volume. Therefore the clinical practice of etomidate and propofol in admixture for the induction and maintenance of general anesthesia in adult patients is standard of care and well founded in the anesthesiology literature. However, there are several important questions about which potential ratio of both drugs provides the best combination of favorable cardiopulmonary effects while having an acceptably low incidence of adverse effects. Thus, this current proposed trial is intended to answer several important questions on that matter.

This trial also will have actual blinding of both patients and practitioners at time of drug administration. Propofol is a white liquid and etomidate is a clear liquid. Thus, past trials where either pure drug was given in sequence or at the same time by separate syringes could not have had any blinding because of this obvious physical quality of the medications. Therefore, only a trial involving an admixture of varying ratios of both drugs could possibly hope to achieve actual blinding as is required for rigorous analysis of results without introducing the bias that comes from a lack of true blinding of patients and practitioners.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (age ≥18 years old)
  • Having endoscopic procedure at CUH with anesthesia
  • ASA 3 or above
  • Ejection Fraction test result available

Exclusion criteria

  • Known allergies or adverse reactions to study drugs or study drug components or preservatives
  • Patient refusal
  • Clinician refusal
  • Documented cognitive impairments precluding subject ability to consent for themselves unless a surrogate documented legally acceptable decision maker consents for patient participation
  • Prisoner or incarcerated or patients held by law enforcement officials in custody
  • Pregnancy or patient refusal for pregnancy testing or screening (standard UTSW policy and protocol requires pregnancy testing for appropriate patients prior to anesthesia)

Treatment and study plan

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

Drug

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).

The objectives are to compare the treatment arms, P2E7 and P7E2, in a randomized controlled double-blind trial for anesthesia for endoscopic procedures. Comparison between an admixture of Propofol/Etomidate 75%/25% versus 25%/75% being utilized as principal anesthetic for endoscopic procedures at CUH endoscopy lab.

Other names: propofol, etomidate, P7E2, propofol 75% by volume, etomidate 25% by volume

Admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7)

Drug

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).

The objectives are to compare the treatment arms, P2E7 and P7E2, in a randomized controlled double-blind trial for anesthesia for endoscopic procedures. Comparison between an admixture of Propofol/Etomidate 75%/25% versus 25%/75% being utilized as principal anesthetic for endoscopic procedures at CUH endoscopy lab.

Other names: propofol, etomidate, P2E7, propofol 25% by volume, etomidate 75% by volume

Primary outcomes

  1. Time weighted average mean arterial pressure within treatment arm

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Time weighted average mean arterial pressure (every 15 minutes calculate average mean arterial pressure for that interval, then end of case calculate mean of all those means for the entire case)

  2. Average within treatment arm vasopressor use by number of units

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Vasopressor use by number of units (1 unit of vasopressor being defined as 1 unit vasopressor = 100 mcg phenylephrine = 5 mg ephedrine = 0.5 units vasopressin = 5 mcg norepinephrine)4-9 throughout entire intraoperative period (subjects on vasopressor infusions on arrival for endoscopy will not have those vasopressor units added in UNLESS during case, anesthesia clinicians adjust the infusion based on intraoperative clinical situation as well as all bolus doses and new infusions being added as with all other subjects)

  3. Average within treatment arm total minutes under 92% oxygen saturation

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Average within treatment arm total minutes under 92% oxygen saturation by pulse oximetry during entire case

  4. % of cases with any MAP below 50

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    % of cases with any MAP below 50

  5. % of cases with any MAP >60% below patient's immediate preoperative MAP

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    % of cases with any MAP >60% below patient's immediate preoperative MAP

  6. % of cases with any treatment for Post Operative Nausea and Vomiting

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    % of cases with any treatment for Post Operative Nausea and Vomiting

  7. % of cases with any oxygen saturation event below 85% by pulse oximetry

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    % of cases with any oxygen saturation event below 85% by pulse oximetry

  8. % of cases with any rapid response or code blue event within 24 hours from anesthesia start

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    % of cases with any rapid response or code blue event within 24 hours from anesthesia start

  9. Within treatment arm % of total group with a composite MACE event in the 30 days

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Within treatment arm % of total group with a composite MACE event in the 30 days after starting on day of drug administration

  10. Within treatment arm % of total group with a classic MACE event in the 30 days

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Within treatment arm % of total group with a classic MACE event in the 30 days after starting on day of drug administration

  11. Average within treatment arm antiemetic use by number of doses

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Average within treatment arm antiemetic use by number of doses irrespective of antiemetic drug choice

  12. Average within treatment arm time in minutes after dressing complete to discharge

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Average within treatment arm time in minutes after dressing complete to discharge to next phase of care or to home from immediate recovery phase of care

Secondary outcomes

  1. Within each treatment arm, average of anesthesia clinicians' assessment of quality

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Within each treatment arm, average of anesthesia clinicians' assessment of quality of anesthesia during case: Poor, Below Average, Average, Above Average, Excellent (0,1,2,3,4) from all anesthesia staff then average for each treatment arm

  2. Within each treatment arm, average of endoscopists' assessment of quality

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Within each treatment arm, average of endoscopists' assessment of quality of anesthesia during case: Poor, Below Average, Average, Above Average, Excellent (0,1,2,3,4) from all endoscopy staff then average for each treatment arm

  3. Within each treatment arm, average of patients' assessment of quality

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Within each treatment arm, average of patients' assessment of quality of anesthesia during case: Poor, Below Average, Average, Above Average, Excellent (0,1,2,3,4) from all patients then average for each treatment arm

  4. Within each treatment arm, number of events of any use of 2 or more

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Within each treatment arm, number of events of any use of 2 or more different (beyond study admixtures) sedative or anesthetic adjunct medications

  5. Within each treatment arm, number of events of any use of two or more

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Within each treatment arm, number of events of any use of two or more types of antiemetic drugs

  6. Average time in immediate recovery area before discharge to next phase of care

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Average time in immediate recovery area before discharge to next phase of care or to home

  7. Average time from dressing complete to modified Aldrete score >8

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Average time from dressing complete to modified Aldrete score >8

  8. Within each treatment arm number of composite MACE events in the 30 days

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Within each treatment arm number of composite MACE events in the 30 days after starting on day of drug administration

  9. Within each treatment arm number of classic MACE events in the 30 days

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Within each treatment arm number of classic MACE events in the 30 days after starting on day of drug administration

  10. Average within treatment arm total dose (mL) of admixture administered

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Average within treatment arm total dose (mL) of admixture administered during entire case divided by average time from induction to dressing complete (minutes)

  11. Average within treatment arm total dose (mg) of etomidate during entire case

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Average within treatment arm total dose (mg) of etomidate during entire case divided by average time from induction to dressing complete (minutes)

  12. Average within treatment arm total dose (mg) of propofol during entire case

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Average within treatment arm total dose (mg) of propofol during entire case divided by average time from induction to dressing complete (minutes)

  13. Average within treatment arm total dose of adjunct sedatives

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Average within treatment arm total dose of fentanyl, sufentanil, midazolam, diphenhydramine, ketamine, morphine, hydromorphone, dexmedetomidine, undiluted propofol, undiluted etomidate (either in mcg or mg as appropriate for each drug) divided by average time from induction to dressing complete (minutes)

  14. Within each treatment arm, number of events of any episode of vomiting

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Within each treatment arm, number of events of any episode of vomiting

  15. Within each treatment arm, number of events of any complaint of nausea

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Within each treatment arm, number of events of any complaint of nausea

  16. Within each treatment arm, number of events of any syncopal event

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Within each treatment arm, number of events of any syncopal event

  17. Within each treatment arm, number of events of any use of one type of antiemetic drug

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Within each treatment arm, number of events of any use of one type of antiemetic drug

  18. Within each treatment arm, number of events of any unanticipated admission

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Within each treatment arm, number of events of any unanticipated admission, or transfer to higher level of care in the 24 hours after starting on day of drug administration

  19. Within each treatment arm, number of events of any airway adjunct usage

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Within each treatment arm, number of events of any airway adjunct usage (oral airway, nasal airway, need for intermittent mask ventilation)

  20. Within each treatment arm, number of events of any use of any additional sedatives

    Time frame: Throughout entire study estimated to take 6 to 12 months to complete

    Within each treatment arm, number of events of any use of any additional sedative or anesthetic adjunct medication (beyond study admixtures) during case (fentanyl, sufentanil, midazolam, diphenhydramine, ketamine, morphine, hydromorphone, dexmedetomidine, undiluted propofol, undiluted etomidate)

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Choi

CONTACT

[email protected]

2146486400

Kapil Anand

CONTACT

[email protected]

2146486400

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Acronym: PEAC

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 3, 2022
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.