Propofol and Etomidate Admixtures Comparisons Trial (PEAC Trial)

NCT05358535 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: STU-2022-0377
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Anesthesia; Propofol Adverse Reaction; Etomidate Adverse Reaction; Anesthesia Complication; Anesthesia; Adverse Effect; Anesthesia; Reaction

Keywords

anesthesia; anesthesiology; adverse drug reaction; drug side effect; sedation; cardiopulmonary; hemodynamics

Outcome Measures

Primary Outcomes (12)

• Time weighted average mean arterial pressure within treatment arm

  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)

  Throughout entire study estimated to take 6 to 12 months to complete

• Average within treatment arm vasopressor use by number of units

  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)

  Throughout entire study estimated to take 6 to 12 months to complete

• Average within treatment arm total minutes under 92% oxygen saturation

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

  Throughout entire study estimated to take 6 to 12 months to complete

• % of cases with any MAP below 50

  % of cases with any MAP below 50

  Throughout entire study estimated to take 6 to 12 months to complete

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

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

  Throughout entire study estimated to take 6 to 12 months to complete

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

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

  Throughout entire study estimated to take 6 to 12 months to complete

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

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

  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

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

  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

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

  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

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

  Throughout entire study estimated to take 6 to 12 months to complete

• Average within treatment arm antiemetic use by number of doses

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

  Throughout entire study estimated to take 6 to 12 months to complete

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

  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

  Throughout entire study estimated to take 6 to 12 months to complete

Secondary Outcomes (20)

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

  Throughout entire study estimated to take 6 to 12 months to complete

• Within each treatment arm, average of endoscopists' assessment of quality

  Throughout entire study estimated to take 6 to 12 months to complete

• Within each treatment arm, average of patients' assessment of quality

  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

  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

  Throughout entire study estimated to take 6 to 12 months to complete

Study Arms (2)

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

EXPERIMENTAL

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.

Drug: 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)

EXPERIMENTAL

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.

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

Interventions

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.

Also known as: propofol, etomidate, P7E2, propofol 75% by volume, etomidate 25% by volume

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) 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.

Also known as: propofol, etomidate, P2E7, propofol 25% by volume, etomidate 75% by volume

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Clements University Hospital

Dallas, Texas, 75390, United States

RECRUITING

Related Publications (7)

• Chen L, Liang X, Tan X, Wen H, Jiang J, Li Y. Safety and efficacy of combined use of propofol and etomidate for sedation during gastroscopy: Systematic review and meta-analysis. Medicine (Baltimore). 2019 May;98(20):e15712. doi: 10.1097/MD.0000000000015712.

  PMID: 31096522 BACKGROUND

• Yoon SW, Choi GJ, Lee OH, Yoon IJ, Kang H, Baek CW, Jung YH, Woo YC. Comparison of propofol monotherapy and propofol combination therapy for sedation during gastrointestinal endoscopy: A systematic review and meta-analysis. Dig Endosc. 2018 Sep;30(5):580-591. doi: 10.1111/den.13050. Epub 2018 Apr 17.

  PMID: 29526045 BACKGROUND

• Hao L, Hu X, Zhu B, Li W, Huang X, Kang F. Clinical observation of the combined use of propofol and etomidate in painless gastroscopy. Medicine (Baltimore). 2020 Nov 6;99(45):e23061. doi: 10.1097/MD.0000000000023061.

  PMID: 33157963 BACKGROUND

• Goradia S, Sardaneh AA, Narayan SW, Penm J, Patanwala AE. Vasopressor dose equivalence: A scoping review and suggested formula. J Crit Care. 2021 Feb;61:233-240. doi: 10.1016/j.jcrc.2020.11.002. Epub 2020 Nov 14.

  PMID: 33220576 BACKGROUND

• Saravanan S, Kocarev M, Wilson RC, Watkins E, Columb MO, Lyons G. Equivalent dose of ephedrine and phenylephrine in the prevention of post-spinal hypotension in Caesarean section. Br J Anaesth. 2006 Jan;96(1):95-9. doi: 10.1093/bja/aei265. Epub 2005 Nov 25.

  PMID: 16311286 BACKGROUND

• French WB, Rothstein WB, Scott MJ. Time to Use Peripheral Norepinephrine in the Operating Room. Anesth Analg. 2021 Jul 1;133(1):284-288. doi: 10.1213/ANE.0000000000005558. No abstract available.

  PMID: 33886514 BACKGROUND

• Mohta M, Dubey M, Malhotra RK, Tyagi A. Comparison of the potency of phenylephrine and norepinephrine bolus doses used to treat post-spinal hypotension during elective caesarean section. Int J Obstet Anesth. 2019 May;38:25-31. doi: 10.1016/j.ijoa.2018.12.002. Epub 2018 Dec 13.

  PMID: 30685301 BACKGROUND

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Propofol; Etomidate

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kapil Anand

  University of Texas

  STUDY DIRECTOR

Central Study Contacts

Christopher Choi

CONTACT

2146486400; christopher.choi@utsouthwestern.edu

Kapil Anand

CONTACT

2146486400; kapil.anand@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Blinding plan: Either the investigational drug service with the CUH central pharmacy will prepare the admixture syringes or a separate anesthesia staff not involved in subject's case will prepare admixture syringes thus preventing any case personnel involved with subject's case or subject from knowing which admixture is present within syringes for subject's case.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology and Pain Management

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 3, 2022
• Study Start: September 19, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: At conclusion of all data analysis and available permanently
• Access Criteria: Only study personnel

Locations

US (1)