Etomidate to Improve Outcome in Elderly Patients (EPIC)

Zhihong LU

Status: Completed

Conditions: Postoperative Complications

Treatments: Drug: Sufentanil; Drug: Etomidate; Drug: Cisatracurium; Drug: propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT02910206

XJH-A-2015-12-01

Details and patient eligibility

About

Elderly patients have high mortality and postoperative complications rate after surgery, especially postoperative cardiac complications. A meta-analysis revealed haemodynamic intraoperative events significantly increased the risk of postoperative cardiac complications.To limit the risk, optimize the intraoperative management of circulation is essential. Anesthetic drug may effect on the haemodynamic intraoperative, reduction of postoperative complications should aimed at choosing the optimal anesthetic drug with minimal effect on haemodynamic.So this study is to explore the comparative efficacy and safety of anesthetic drug (etomidate or propofol) in elderly patients

Enrollment: 1,917 patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged between 65 and 80 years old.
• Patients scheduled for elective gastrointestinal surgery under general anesthesia.

Exclusion criteria

• Expected duration of surgery < 1 or >4 hours
• American Society of Anesthesiologists status >III
• Body Mass Index < 18 kg/m2 or> 25 kg/m2
• Cerebrovascular accident occurred within the previous 3 months,such as stroke or transient ischemic attack
• Unstable angina and myocardial infarction occurred within the previous 3 months
• Patients with serious hepatic dysfunction ( the serum level of alanine transaminase, conjugated bilirubin, aspartate transaminase, alkaline phosphatase or total bilirubin is 2 folds more than upper normal limit) or renal dysfunction(creatinine clearance rate less than 30 milliliter per minute).
• Diabetic patients with complication (diabetic ketoacidosis, hyperosmotic coma,all kinds of infection, macroangiopathy, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot).
• Preoperative blood pressure more than or equal to 180/110 mmHg
• Confirmed or suspected of narcotic analgesics abusing or long term using
• Taking corticosteroids or immunosuppressive agents for more than 10 days with the previous 6 months or had history of adrenal suppression or immune system disease.
• Patients with thyroid hypofunction.
• Patients with history of asthma.
• Patients with history of surgery within previous 3 months.
• Patients allergic or contraindicated to propofol or etomidate
• Patients participated in other study within the last 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,917 participants in 2 patient groups

etomidate

Experimental group

Description:

etomidate is given for maintenance of general anesthesia,combined with sufentanil and cisatracurium

Treatment:

Drug: Cisatracurium

Drug: Sufentanil

Drug: Etomidate

propofol

Experimental group

Description:

propofol is given for maintenance of general anesthesia,combined with sufentanil and cisatracurium

Treatment:

Drug: Cisatracurium

Drug: Sufentanil

Drug: propofol