Etomidate to Improve Outcome in Elderly Patients (EPIC)

Comparative Effect of Etomidate and Propofol on Major Complications After Abdominal Surgery in Elderly Patients

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

Study Overview

• Status: Completed
• Conditions: Postoperative Complications
• Intervention / Treatment: Drug: Etomidate; Drug: Sufentanil; Drug: Cisatracurium; Drug: propofol

• Study Type: Interventional
• Enrollment (Actual): 1917
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing hospital, Fourth military medical university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: etomidate; etomidate is given for maintenance of general anesthesia,combined with sufentanil and cisatracurium	Drug: Etomidate; etomidate is given intravenously; Drug: Sufentanil; sufentanil is given intravenously; Drug: Cisatracurium; Cisatracurium is given intravenously
Experimental: propofol; propofol is given for maintenance of general anesthesia,combined with sufentanil and cisatracurium	Drug: Sufentanil; sufentanil is given intravenously; Drug: Cisatracurium; Cisatracurium is given intravenously; Drug: propofol; propofol is given intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with complications defined by ICD (International codes of diseases)-9	From the moment of giving sufentanil to the moment of discharge from hospital,up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the time to awake from anesthesia		From stopping etomidate or propofol infusion to awake, approximately 30 minutes
the time to withdraw tracheal tube from anesthesia		From end of etomidate or propofol infusion to recovery of spontaneous breathing and withdrawal of tracheal tube,approximately 30 minutes
the time to discharge from post-anesthesia care unit		From admit into post-anesthesia care unit to discharge from post-anesthesia care unit,on an average of 30 minutes
the time to discharge from hospital		From end of surgery to discharge from hospital,on an average of 7 days
Post Operative Nausea And vomiting score	score:0,no nausea and vomiting; 1,nausea without vomiting; 2,vomiting	6 hours, 24 hours, 48 hours and 72 hours after end of surgery，approximately 6 hours, 24 hours, 48 hours and 72 hours respectively
pain on visual analogue scale		6 hours after end of surgery，approximately 6 hours
satisfaction on visual analogue scale by the patients	patients will be asked to score their satisfaction on anesthesia on a visual analogue, 0 is for extremely unsatisfied, 10 is for totally satisfied	24 hours after end of surgery
comfort on visual analogue scale by the patients	patients will be asked to score their comfort during and after anesthesia on a visual analogue, 0 is for extremely unsatisfied, 10 is for totally satisfied	24 hours after end of surgery
incidence of hypotension during anesthesia	hypotension is defined as decrease of systemic blood pressure more than 20% of baseline	from start of surgery to end of surgery, on an average of 2.5 hours
incidence of hypertension during anesthesia	hypotension is defined as increase of systemic blood pressure more than 20% of baseline	from start of surgery to end of surgery, on an average of 2.5 hours
percentage of patients needed vasoactive agents during anesthesia		from start of surgery to end of surgery, on an average of 2.5 hours
concentration of serum Cortisol by radioimmunoassay		24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively
concentration of serum aldosterone by radioimmunoassay		24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively
concentration of serum Adrenocorticotropichormone(ACTH) by radioimmunoassay		24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively
death by 6 months after surgery		from end of surgery to 6 months after surgery
death by 12 months after surgery		from end of surgery to 12 months after surgery

Collaborators and Investigators

• Sponsor: Zhihong LU
• Investigators: Study Chair: Lize Xiong, PhD, Xijing Hosptial

Publications and helpful links

General Publications

• Du Y, Chen YJ, He B, Wang YW. The Effects of Single-Dose Etomidate Versus Propofol on Cortisol Levels in Pediatric Patients Undergoing Urologic Surgery: A Randomized Controlled Trial. Anesth Analg. 2015 Dec;121(6):1580-5. doi: 10.1213/ANE.0000000000000981.
• Aghdaii N, Ziyaeifard M, Faritus SZ, Azarfarin R. Hemodynamic Responses to Two Different Anesthesia Regimens in Compromised Left Ventricular Function Patients Undergoing Coronary Artery Bypass Graft Surgery: Etomidate-Midazolam Versus Propofol-Ketamine. Anesth Pain Med. 2015 Jun 22;5(3):e27966. doi: 10.5812/aapm.27966v2. eCollection 2015 Jun.
• Song JC, Lu ZJ, Jiao YF, Yang B, Gao H, Zhang J, Yu WF. Etomidate Anesthesia during ERCP Caused More Stable Haemodynamic Responses Compared with Propofol: A Randomized Clinical Trial. Int J Med Sci. 2015 Jul 3;12(7):559-65. doi: 10.7150/ijms.11521. eCollection 2015.
• Kaushal RP, Vatal A, Pathak R. Effect of etomidate and propofol induction on hemodynamic and endocrine response in patients undergoing coronary artery bypass grafting/mitral valve and aortic valve replacement surgery on cardiopulmonary bypass. Ann Card Anaesth. 2015 Apr-Jun;18(2):172-8. doi: 10.4103/0971-9784.154470.
• Lu Z, Zheng H, Chen Z, Xu S, Chen S, Mi W, Wang T, Chai X, Guo Q, Zhou H, Yu Y, Zheng X, Zhang J, Ai Y, Yu B, Bao H, Zheng H, Huang W, Wu A, Deng X, Ma H, Ma W, Tao L, Yang X, Zhang J, Liu T, Ma HP, Liang W, Wang X, Zhang Y, Du W, Ma T, Xie Y, Xie Y, Li N, Yang Y, Zheng T, Zhang C, Zhao Y, Dong R, Zhang C, Zhang G, Liu K, Wu Y, Fan X, Tan W, Li N, Dong H, Xiong L. Effect of Etomidate vs Propofol for Total Intravenous Anesthesia on Major Postoperative Complications in Older Patients: A Randomized Clinical Trial. JAMA Surg. 2022 Oct 1;157(10):888-895. doi: 10.1001/jamasurg.2022.3338.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): November 20, 2020

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: September 20, 2016
• First Posted (Estimate): September 21, 2016

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: propofol; etomidate
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Neuromuscular Agents; Neuromuscular Blocking Agents; Propofol; Sufentanil; Etomidate; Cisatracurium
• Other Study ID Numbers: XJH-A-2015-12-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No