Anesthesia Clinical Trial
— PEACOfficial title:
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).
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Clements University Hospital | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
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. — View Citation
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. Erratum In: Anesth Analg. 2021 Nov 1;133(5):e62. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | % 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 | |
Primary | % 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 | |
Primary | % 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 | |
Primary | % 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 | |
Primary | % 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | Throughout entire study estimated to take 6 to 12 months to complete | |
Secondary | 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 | Throughout entire study estimated to take 6 to 12 months to complete | |
Secondary | 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 | Throughout entire study estimated to take 6 to 12 months to complete | |
Secondary | 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 | Throughout entire study estimated to take 6 to 12 months to complete | |
Secondary | 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 | Throughout entire study estimated to take 6 to 12 months to complete | |
Secondary | 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 | Throughout entire study estimated to take 6 to 12 months to complete | |
Secondary | Average time from dressing complete to modified Aldrete score >8 | Average time from dressing complete to modified Aldrete score >8 | Throughout entire study estimated to take 6 to 12 months to complete | |
Secondary | 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 | Throughout entire study estimated to take 6 to 12 months to complete | |
Secondary | 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 | Throughout entire study estimated to take 6 to 12 months to complete | |
Secondary | 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) | Throughout entire study estimated to take 6 to 12 months to complete | |
Secondary | 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) | Throughout entire study estimated to take 6 to 12 months to complete | |
Secondary | 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) | Throughout entire study estimated to take 6 to 12 months to complete | |
Secondary | 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) | Throughout entire study estimated to take 6 to 12 months to complete | |
Secondary | Within each treatment arm, number of events of any episode of vomiting | Within each treatment arm, number of events of any episode of vomiting | Throughout entire study estimated to take 6 to 12 months to complete | |
Secondary | Within each treatment arm, number of events of any complaint of nausea | Within each treatment arm, number of events of any complaint of nausea | Throughout entire study estimated to take 6 to 12 months to complete | |
Secondary | Within each treatment arm, number of events of any syncopal event | Within each treatment arm, number of events of any syncopal event | Throughout entire study estimated to take 6 to 12 months to complete | |
Secondary | 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 | Throughout entire study estimated to take 6 to 12 months to complete | |
Secondary | 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 | Throughout entire study estimated to take 6 to 12 months to complete | |
Secondary | 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) | Throughout entire study estimated to take 6 to 12 months to complete | |
Secondary | 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) | Throughout entire study estimated to take 6 to 12 months to complete |
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