AnesthesiaPhase 3PEACNCT05358535
Propofol and Etomidate Admixtures Comparisons Trial (PEAC Trial)
A Phase 3 study testing Admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2) and Admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7) in people with Anesthesia and Propofol Adverse Reaction, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Propofol Adverse Reaction, Etomidate Adverse Reaction
- What is being tested?
- Admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2) and Admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2022to Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age ≥18 years old)
- Having endoscopic procedure at CUH with anesthesia
- ASA 3 or above
- Ejection Fraction test result available
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Clements University Hospital
Dallas, Texas, 75390
Joseph M Hendrix, MD, 8172667987
About this study
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).
Read the detailed description
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.
- Conditions
- Anesthesia, Propofol Adverse Reaction, Etomidate Adverse Reaction, Anesthesia Complication, Anesthesia; Adverse Effect, Anesthesia; Reaction
- Being tested
- 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)
- Keywords
- anesthesia, anesthesiology, adverse drug reaction, drug side effect, sedation, cardiopulmonary, hemodynamics
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2)Drug
Also called propofol, etomidate, P7E2, propofol 75% by volume
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)Drug
Also called propofol, etomidate, P2E7, propofol 25% by volume
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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
Measured: Throughout entire study estimated to take 6 to 12 months to complete
Within each treatment arm, average of endoscopists' assessment of quality
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
Measured: Throughout entire study estimated to take 6 to 12 months to complete
Within each treatment arm, average of patients' assessment of quality
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
Measured: 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
Within each treatment arm, number of events of any use of 2 or more different (beyond study admixtures) sedative or anesthetic adjunct medications
Measured: 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
Within each treatment arm, number of events of any use of two or more types of antiemetic drugs
Measured: 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
Average time in immediate recovery area before discharge to next phase of care or to home
Measured: Throughout entire study estimated to take 6 to 12 months to complete
Average time from dressing complete to modified Aldrete score >8
Average time from dressing complete to modified Aldrete score >8
Measured: 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
Within each treatment arm number of composite MACE events in the 30 days after starting on day of drug administration
Measured: 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
Within each treatment arm number of classic MACE events in the 30 days after starting on day of drug administration
Measured: Throughout entire study estimated to take 6 to 12 months to complete
Average within treatment arm total dose (mL) of admixture administered
Average within treatment arm total dose (mL) of admixture administered during entire case divided by average time from induction to dressing complete (minutes)
Measured: Throughout entire study estimated to take 6 to 12 months to complete
Average within treatment arm total dose (mg) of etomidate during entire case
Average within treatment arm total dose (mg) of etomidate during entire case divided by average time from induction to dressing complete (minutes)
Measured: Throughout entire study estimated to take 6 to 12 months to complete
Average within treatment arm total dose (mg) of propofol during entire case
Average within treatment arm total dose (mg) of propofol during entire case divided by average time from induction to dressing complete (minutes)
Measured: Throughout entire study estimated to take 6 to 12 months to complete
Average within treatment arm total dose of adjunct sedatives
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)
Measured: Throughout entire study estimated to take 6 to 12 months to complete
Within each treatment arm, number of events of any episode of vomiting
Within each treatment arm, number of events of any episode of vomiting
Measured: Throughout entire study estimated to take 6 to 12 months to complete
Within each treatment arm, number of events of any complaint of nausea
Within each treatment arm, number of events of any complaint of nausea
Measured: Throughout entire study estimated to take 6 to 12 months to complete
Within each treatment arm, number of events of any syncopal event
Within each treatment arm, number of events of any syncopal event
Measured: 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
Within each treatment arm, number of events of any use of one type of antiemetic drug
Measured: Throughout entire study estimated to take 6 to 12 months to complete
Within each treatment arm, number of events of any unanticipated admission
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
Measured: Throughout entire study estimated to take 6 to 12 months to complete
Within each treatment arm, number of events of any airway adjunct usage
Within each treatment arm, number of events of any airway adjunct usage (oral airway, nasal airway, need for intermittent mask ventilation)
Measured: 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 sedatives
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)
Measured: Throughout entire study estimated to take 6 to 12 months to complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start19 Sep 2022
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Choi, University of Texas Southwestern Medical Center
- Investigators
- Kapil Anand, Study director, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358535
- Sponsor's protocol ID
- STU-2022-0377
- Acronym
- PEAC
- Status last verified
- Jan 2026
- First submitted
- 21 Apr 2022
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. PHI (name, date of birth, Medical Record number, phone number, email account, admission date) 2. Demographics (Age, height, weight, BMI) 3. Medical history 4. Medication list Intraoperative data collection * 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) Area Under the Threshold for mean arterial pressure (both predefined threshold of 65 mm Hg and for 40% below patient's immediate preoperative MAP) * 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)
Publications
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.
PubMed 31096522Yoon 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.
PubMed 29526045Hao 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.
PubMed 33157963Goradia 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.
PubMed 33220576Saravanan 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.
PubMed 16311286French 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.
PubMed 33886514Mohta 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.
PubMed 30685301
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol and Etomidate Admixtures Comparisons Trial (PEAC Trial)
- ClinicalTrials.gov ID
- NCT05358535
- Acronym / sponsor ID
- PEAC / STU-2022-0377
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2) | Experimental | Drug: 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. |
| Admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7) | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (age ≥18 years old)
- Having endoscopic procedure at CUH with anesthesia
- ASA 3 or above
- Ejection Fraction test result available
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2)Also: propofol, etomidate, P7E2, propofol 75% by volumeThe 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. | 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)Also: propofol, etomidate, P2E7, propofol 25% by volumeThe 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. | Drug | Admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7) |
Primary outcome
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)
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)
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
% 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
% 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
% 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
% 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
% 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
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
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
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
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
20 secondary outcomes
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 endoscopists' 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
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
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
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
Time frame: Throughout entire study estimated to take 6 to 12 months to complete
Average time from dressing complete to modified Aldrete score >8
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
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
Time frame: Throughout entire study estimated to take 6 to 12 months to complete
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 (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 propofol during entire case
Time frame: Throughout entire study estimated to take 6 to 12 months to complete
Average within treatment arm total dose of adjunct sedatives
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
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
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
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
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
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
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 sedatives
Time frame: Throughout entire study estimated to take 6 to 12 months to complete
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Background: PubMed 31096522Chen 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.
- Background: PubMed 29526045Yoon 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.
- Background: PubMed 33157963Hao 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.
- Background: PubMed 33220576Goradia 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.
- Background: PubMed 16311286Saravanan 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.
- Background: PubMed 33886514French 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.
- Background: PubMed 30685301Mohta 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.
- Individual participant dataSharing planned: Yes. 1. PHI (name, date of birth, Medical Record number, phone number, email account, admission date) 2. Demographics (Age, height, weight, BMI) 3. Medical history 4. Medication list Intraoperative data collection * 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) Area Under the Threshold for mean arterial pressure (both predefined threshold of 65 mm Hg and for 40% below patient's immediate preoperative MAP) * 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kapil Anand study director
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2) and Admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7) in people with Anesthesia and Propofol Adverse Reaction, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Choi (2146486400, christopher.choi@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05358535, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.