Propofol and Etomidate Admixtures Comparisons Trial (PEAC Trial)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center

About 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (age ≥18 years old)

Having endoscopic procedure at CUH with anesthesia

ASA 3 or above

Ejection Fraction test result available

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2)Experimental treatment 1 intervention
Group B: Admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Throughout entire study estimated to take 6 to 12 months to complete
2

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)

Time frame
Throughout entire study estimated to take 6 to 12 months to complete
3

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

Time frame
Throughout entire study estimated to take 6 to 12 months to complete
4

% of cases with any MAP below 50

% of cases with any MAP below 50

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

Secondary outcomes

1

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

Time frame
Throughout entire study estimated to take 6 to 12 months to complete
2

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

Time frame
Throughout entire study estimated to take 6 to 12 months to complete
3

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

Time frame
Throughout entire study estimated to take 6 to 12 months to complete
4

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

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

Other outcomes

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