Recruiting
Phase 3

Propofol & Etomidate

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT05358535

Conditions

Anesthesia

Propofol Adverse Reaction

Etomidate Adverse Reaction

Anesthesia Complication

Anesthesia; Adverse Effect

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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)

Study Details

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

Study ID

NCT05358535

Start date

Sep 19, 2022

Status verified date

Jan, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

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

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.

Interventions

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

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.

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

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.

Primary outcome measure

  • Time weighted average mean arterial pressure within treatment arm [ Time Frame: Throughout entire study estimated to take 6 to 12 months to complete ]
  • Average within treatment arm vasopressor use by number of units [ Time Frame: Throughout entire study estimated to take 6 to 12 months to complete ]
  • Average within treatment arm total minutes under 92% oxygen saturation [ Time Frame: Throughout entire study estimated to take 6 to 12 months to complete ]
  • % 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 >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 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 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 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 ]
  • 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 classic MACE event in the 30 days [ Time Frame: Throughout entire study estimated to take 6 to 12 months to complete ]
  • 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 time in minutes after dressing complete to discharge [ Time Frame: Throughout entire study estimated to take 6 to 12 months to complete ]

Central Contacts and Locations

Central contacts

Christopher Choi

2146486400christopher.choi@utsouthwestern.edu

Kapil Anand

2146486400kapil.anand@utsouthwestern.edu

Locations

Clements University Hospital

Recruiting

Dallas, Texas, United States, 75390

Contacts

Joseph M Hendrix, MD

8172667987

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-01-20.