Clinical trial
The Safety of Etomidate - Propofol Mixture vs Propofol in Total Intravenous Anesthesia During Abdominal Surgery : a Randomized, Double-blind, Controlled, Multicenter Study
Name
SEPT
Description
The purpose of this study is to access the safety of etomidate - propofol mixture vs propofol in total intravenous anesthesia during abdominal surgery.
Trial arms
Trial start
2023-06-16
Estimated PCD
2024-05-01
Trial end
2024-08-30
Status
Recruiting
Treatment
Etomidate - propofol mixture
Patients will receive etomidate - propofol mixture during induction and maintenance. Sufentanil 0.2-0.7 μg/kg，Cisatracurium 0.15 mg/kg，EP mixture（E：P=1:2） 0.1-0.25 ml/kg for induction, EP mixture 0.4\~ 1.2 ml/kg/h and remifentanil 0.05μg/kg/min \~0.3 μg/kg/min for maintenance.
Arms:
EP group
Other names:
EP
Propofol
Patients will receive propofol during induction and maintenance.Sufentanil 0.2-0.7 μg/kg，Cisatracurium 0.15 mg/kg，propofol 0.1-0.25 ml/kg for induction, propofol 0.4\~ 1.2 ml/kg/h and remifentanil 0.05μg/kg/min \~0.3 μg/kg/min for maintenance.
Arms:
P group
Other names:
P
Size
468
Primary endpoint
Incidence and duration of hypotension during anesthesia
during anesthesia
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 468, 'type': 'ESTIMATED'}}
Updated at
2024-02-23
1 organization
2 products
2 indications
Organization
Ailin LuoProduct
Etomidate + Propofol MixtureIndication
EtomidateIndication
Low blood pressureProduct
Propofol