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

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Anesthesia+5 MoreAdmixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effects of two different ratios of propofol and etomidate on patients undergoing endoscopic procedures.

Eligible Conditions
  • Anesthesia
  • Propofol Adverse Reaction
  • Anesthesia Awareness
  • Etomidate Adverse Reaction
  • Anesthesia Complications
  • Anesthetic Reaction

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

12 Primary · 20 Secondary · Reporting Duration: Throughout entire study estimated to take 6 to 12 months to complete

Month 12
% of cases with any MAP >60% below patient's immediate preoperative MAP
% of cases with any MAP below 50
% 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
% of cases with any treatment for Post Operative Nausea and Vomiting
Average time from dressing complete to modified Aldrete score >8
Average time in immediate recovery area before discharge to next phase of care
Average within treatment arm antiemetic use by number of doses
Average within treatment arm time in minutes after dressing complete to discharge
Average within treatment arm total dose (mL) of admixture administered
Average within treatment arm total dose (mg) of etomidate during entire case
Average within treatment arm total dose (mg) of propofol during entire case
Average within treatment arm total dose of adjunct sedatives
Average within treatment arm total minutes under 92% oxygen saturation
Average within treatment arm vasopressor use by number of units
Time weighted average mean arterial pressure within treatment arm
Within each treatment arm number of classic MACE events in the 30 days
Composite Resins
Within each treatment arm, average of anesthesia clinicians' assessment of quality
Within each treatment arm, average of endoscopists' assessment of quality
Within each treatment arm, average of patients' assessment of quality
Within each treatment arm, number of events of any airway adjunct usage
Within each treatment arm, number of events of any complaint of nausea
Within each treatment arm, number of events of any episode of vomiting
Within each treatment arm, number of events of any syncopal event
Within each treatment arm, number of events of any unanticipated admission
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 any additional sedatives
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 two or more
Within treatment arm % of total group with a classic MACE event in the 30 days
Within treatment arm % of total group with a composite MACE event in the 30 days

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2)
1 of 2
Admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7)
1 of 2

Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: Admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2) · No Placebo Group · Phase 3

Admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2)
Drug
Experimental Group · 1 Intervention: Admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2) · Intervention Types: Drug
Admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7)
Drug
Experimental Group · 1 Intervention: Admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: throughout entire study estimated to take 6 to 12 months to complete

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
953 Previous Clinical Trials
608,492 Total Patients Enrolled
Kapil AnandStudy DirectorUniversity of Texas

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are an adult patient.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Clements University Hospital100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References