Comparing the safety of etomidate-propofol mixture and propofol in anesthesia for abdominal surgery

The Safety of Etomidate - Propofol Mixture vs Propofol in Total Intravenous Anesthesia During Abdominal Surgery : a Randomized, Double-blind, Controlled, Multicenter Study

This study is testing if a mix of etomidate and propofol is safer than just using propofol for anesthesia during abdominal surgeries.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 468 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Tongji Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Wuhan)
• Trial ID: NCT05810363 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety of a mixture of etomidate and propofol compared to propofol alone during total intravenous anesthesia for abdominal surgeries. It aims to address the hemodynamic effects and incidence of hypotension associated with propofol, which can lead to adverse cardiovascular events. By combining etomidate, which has minimal hemodynamic effects, with propofol, the study seeks to enhance patient safety and recovery. The trial will include patients undergoing elective abdominal surgery with a planned anesthesia duration of 1 to 4 hours.

Who should consider this trial

Good fit: Ideal candidates are patients classified as ASA I-III with a BMI between 18-28 kg/m2, scheduled for elective abdominal surgery under intravenous general anesthesia.

Not a fit: Patients with conditions such as severe liver or renal dysfunction, uncontrolled diabetes, or recent cardiovascular events may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce the risk of hypotension and improve overall safety during abdominal surgeries.

How similar studies have performed: Previous studies have shown that combining anesthetic agents can mitigate adverse effects, suggesting potential success for this approach.

Eligibility 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:

* Pregnant patients;
* 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;
* Patients who participated in other drug trials within 3 months;
* Patients with disturbance of consciousness or other mental diseases;
* Confirmed/suspected abuse or long-term use of narcotic sedatives and analgesics；
* Patients with cancer who received neoadjuvant therapy or chemotherapy before surgery;
* Allergic to the drug used in this trial and its components.

Where this trial is running

Wuhan

• Tongji hospital — Wuhan, China (RECRUITING)

Study contacts

• Principal investigator: Ailin Luo, Dr — Department of Anesthesiology of Tongji Hospital
• Study coordinator: Ailin Luo, Dr

Conditions: Etomidate, Hypotension