Etomidate–propofol mixture versus propofol for anesthesia in older adults having abdominal surgery
Safety of Etomidate-propofol Mixture vs. Propofol for Total Intravenous Anesthesia in Elderly Patients Undergoing Abdominal Surgery - A Randomized, Double-blind, Controlled Study
NA · Tongji Hospital · NCT07019246
This trial will test whether mixing etomidate with propofol is safer than propofol alone for total intravenous anesthesia in older adults undergoing abdominal surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 65 Years to 80 Years |
| Sex | All |
| Sponsor | Tongji Hospital (other) |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT07019246 on ClinicalTrials.gov |
What this trial studies
Researchers will compare a mixture of etomidate and propofol to propofol alone for total intravenous anesthesia in older adults having elective abdominal operations. Eligible participants (ASA I–III, BMI 18–28) who expect 1–4 hours of anesthesia will receive one of the two anesthesia regimens during surgery and will be monitored closely. The study will record intraoperative hypotension, perioperative cardiovascular events, and measures of adrenal cortical function in the 48 hours after surgery. Safety outcomes, awakening times, and postoperative complications will be compared between the two groups.
Who should consider this trial
Good fit: Ideal candidates are older adults scheduled for elective abdominal surgery lasting 1–4 hours who are ASA physical status I–III with BMI 18–28.
Not a fit: Patients with recent sepsis or multiple organ failure, severe liver or kidney dysfunction, recent stroke or major cardiac events, uncontrolled diabetes with complications, or those undergoing liver, kidney, or adrenal surgery are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, this approach could lower the rate of intraoperative hypotension and reduce perioperative cardiovascular complications while maintaining rapid recovery.
How similar studies have performed: Prior studies show etomidate preserves blood pressure better than propofol but causes temporary adrenal suppression, and combining the drugs is a plausible but not yet well-established strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA Ⅰ\~Ⅲ; * BMI was 18-28 kg/m2; * For elective abdominal surgery under intravenous general anesthesia; * The expected duration of anesthesia was 1 to 4 hours. Exclusion Criteria: * Septic shock and multiple organ failure diagnosed within 14 days; * Hyperkalemia (serum potassium \>5.5mmol/L) within 48 hours; * Stroke or transient ischemic attack within 3 months; * Patients with unstable angina pectoris or myocardial infarction within 3 months; Arrhythmia requiring treatment was not treated or treatment did not meet expectations; * Patients with preoperative diagnosed diabetes mellitus and uncontrolled blood glucose; Diabetic complications were diagnosed before surgery, including diabetic ketoacidosis, hyperosmolar coma, diabetes-related infection, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc. * Severe liver and renal dysfunction; * Liver surgery, renal surgery, adrenal surgery, day surgery; * Resting blood pressure ≥180/110 mmHg (2020 ISH hypertension guideline ≥ grade 3 hypertension); Or systolic blood pressure \<90mmHg or mean blood pressure \<65mmHg. * Taking corticosteroids or other immunosuppressants for more than 10 days within 6 months or having a history of adrenal cortex suppression or immune system diseases;
Where this trial is running
Wuhan, Hubei
- Tongji hospital — Wuhan, Hubei, China (RECRUITING)
Study contacts
- Principal investigator: Shiyong Li — Department of Anesthesiology of Tongji Hospital
- Study coordinator: Shiyong Li
- Email: shiyongli@hust.edu.cn
- Phone: 02783665480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Etomidate Combined With Propofol, Hypertension