Etomidate to Improve Outcome in Elderly Patients (EPIC)

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ClinicalTrials.gov Identifier: NCT02910206

Recruitment Status : Completed

First Posted : September 21, 2016

Last Update Posted : December 10, 2020

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Zhihong LU, Air Force Military Medical University, China

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Postoperative Complications	Drug: Etomidate Drug: propofol Drug: Sufentanil Drug: Cisatracurium	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1917 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:	participants were anesthetized and were unaware of the grouping. Care providers did not know the grouping. Specific investigators who did the intervention were aware of the grouping. The outcome assessors and the data analyzers did not know the grouping.
Primary Purpose:	Treatment
Official Title:	Comparative Effect of Etomidate and Propofol on Major Complications After Abdominal Surgery in Elderly Patients
Actual Study Start Date :	August 15, 2017
Actual Primary Completion Date :	November 20, 2019
Actual Study Completion Date :	November 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Drug Information available for: Propofol Etomidate

U.S. FDA Resources

Arms and Interventions

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: propofol propofol is given intravenously Drug: Sufentanil sufentanil is given intravenously Drug: Cisatracurium Cisatracurium is given intravenously

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	65 Years to 80 Years (Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910206

Locations

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China, Shaanxi
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032

Sponsors and Collaborators

Zhihong LU

Investigators

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Study Chair:	Lize Xiong, PhD	Xijing hosptial

More Information

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Zhihong LU, Dr., Air Force Military Medical University, China
ClinicalTrials.gov Identifier:	NCT02910206
Other Study ID Numbers:	XJH-A-2015-12-01
First Posted:	September 21, 2016 Key Record Dates
Last Update Posted:	December 10, 2020
Last Verified:	December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Zhihong LU, Air Force Military Medical University, China:


etomidate propofol

Additional relevant MeSH terms:

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Postoperative Complications Pathologic Processes Sufentanil Propofol Etomidate Cisatracurium Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anesthetics, Intravenous	Anesthetics, General Anesthetics Analgesics, Opioid Narcotics Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Neuromuscular Blocking Agents Neuromuscular Agents

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